DETAILED ACTION
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 the Claims
Claims 29-42 are pending in the present application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 15 September 2025, 28 October 2025, 3 March 2026, 28 May 2026 and 13 July 2026 were filed before the mailing of an Office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 32 and 39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 32 and 39 recite “medium chain triglycerides”. The instant specification states that medium chain triglycerides are compounds of formula CH2(OR1)-CH(OR2)-CH2(OR3) where R1, R2 and R3 are medium chain fatty acid groups, generally of formula -C(=O)(CH2)nCH3 where n is in the range 4 to 10, for example 6 to 8. Medium-chain fatty acids are fatty acids which have an aliphatic tail of 6-12 carbon atoms. The aliphatic tail is predominantly saturated. Particular medium-chain fatty acids include caproic acid (hexanoic acid, C6:0), caprylic acid (octanoic acid, C8:0), capric acid (decanoic acid, C10:0) and lauric acid (dodecanoic acid, C12:0). Myristic acid (tetradecanoic acid, C14:0) can also be present in minor amounts.
Therefore, it is unclear what compounds are included in the term “medium chain triglyceride” since the definition in the specification recites “generally of formula” which is not limiting to the formula, and the specification states that medium chain fatty acids have an aliphatic tail of 6-12 carbon atoms, but also states that myristic acid (tetradecanoic acid, C14:0) can also be present. Myristic acid is outside the scope of the fatty acids having an aliphatic tail of 6-12 carbon atoms. Therefore, it is unclear whether the medium chain triglycerides are limited to fatty acid groups having an aliphatic tail of 6-12 carbon atoms or includes other fatty acid groups, such as myristic acid.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 35 and 40-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawaguchi et al. (JP 2017-19725 A) in view of Nakajima (US 2019/0040031 A1).
Regarding claims 35 and 40-42, Kawaguchi et al. disclose a whitening agent comprising a melanin production inhibitor including urolithin A ([0009]-[0013], [0015], [0017], [0033]-[0035]; Claims 1-4). Kawaguchi et al. disclose that the urolithin A may be used alone or may contain excipients, including an absorption promoter, solvent, surfactant, etc. ([0035], [0037], [0043]). The urolithin is present in the composition in an amount of 0.00001-10 mass%, preferably 0.0001-3% by weight, more preferably 0.003 to 1% by weight ([0036], [0038], [0042]). When used as a raw material for cosmetics, the composition can be prepared in the form of a cream ([0040], [0062]-[0065]).
Kawaguchi et al. specifically disclose an example wherein a cosmetic cream comprising urolithin A, ethanol, glycerin, water, squalane, bees wax, refined jojoba oil, glycerol monostearate and polyoxyethylene (20) sorbitan monostearate is applied to the skin surface of the upper arm, UV was irradiated onto the test site, and the degree of tanning was compared ([0064]).
Regarding the lightening of skin color or lightening skin tone, and decreasing melanin in skin of the subject, Kawaguchi et al. disclose that the urolithin A compositions are whitening agents and melanin production inhibitors. Therefore, the application of the composition according to Kawaguchi et al. will necessarily lighten the skin color or lighten the skin tone, and decrease melanin in the skin of the subject.
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 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.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 29-42 are rejected under 35 U.S.C. 103 as being unpatentable over Geetha et al. (IN 2004CH00392 A) in view of Nakajima (US 2019/0040031 A1).
Regarding instant claims 29 and 35, Geetha et al. teach cosmetic compositions for topical application comprising benzo[c]chromen-6-one derivatives, particularly oxygenated dibenzo alpha pyrones, wherein the compositions are useful as skin lightening agents, decrease pigmentation, scars, blemishes, freckles and age spots, improving skin elasticity, tone, reduce fine lines and wrinkles, and protecting against monovalent and divalent cations and free radicals, broad spectrum UV protection, and protecting skin against environmental impurities (pg. 1, Field of the Invention; pg. 2, Objective of the Invention; pg. 3, Summary of Invention). Geetha et al. teach that pure oxygenated DBP, particularly the naturally occurring 3,8-dihydroxy dibenzo-alpha pyrone (DBP, urolithin A) and its congeners have excellent ability to inhibit the enzyme tyrosinase, useful as cosmeceutical ingredient for promoting skin fairness, luminosity boosting, blemish removal, reduction of freckles, age spots and depigmentation; as well as being excellent inhibitors of elastase, collagenase and hyaluronidase, useful in improving skin texture, elasticity, tone, reduction of fine lines and wrinkles; good cyclooxygenase inhibition useful in alleviating inflammatory conditions and prostaglandin’s mediated allergic conditions that can be used topically; and for skin lightening, alleviating stretch marks, kheloid pigmentation, and dark circle removal (pg. 3, Detailed Description; Claim 4). Geetha et al. teach controlling the progression of inflammation and irritation (pg. 3, para. 1). Geetha et al. also teach urolithin A shows good UVA to UVB ratio as well as long range on critical wavelength reflecting on the broad spectrum of UV protection and its potential to boost sunscreen action (Example 7; Table 5).
Geetha et al. teach that the compositions are administered topically, and further comprise excipients (pg. 10, Method 4; Claim 8). Geetha et al. teach compositions comprising glyceryl monostearate, which is a mono-glyceride, and additional excipients (Methods 3-4). Geetha et al. also teach that the compositions are in the form of w/o or o/w emulsions, self-emulsifying preparations, powders, ointments, gels, lotions, liquids, drinks, oils, sprays, sticks, tablets, capsules, spansules, transdermal preparations amongst others (pg. 8-9, Cosmetic Compositions, Methods 2-4; Claim 8).
Geetha et al. do not explicitly disclose an example of treating inflammation of the skin or skin irritation caused by sunlight or UV radiation by topically applying an effective amount of urolithin A or a salt thereof, as instantly claimed. However, Geetha et al. teach that benzo[c]chromen-6-one derivatives, including urolithin A, are suitable for topical treatment of inflammation and irritation of the skin as well as providing broad spectrum UV protection due to its longer critical wavelength (pg. 3, para. 1-2; pg. 4, para. 2-3, Detailed Description; Example 7; Method 4; Claim 7). Geetha et al. also teach that the production of melanin by specialized cells called melanocytes in the basal layer, occurs through the action of the enzyme tyrosinase. The rate limiting step in melanogenesis is the conversion of L-tyrosine to melanin, through the action of tyrosinase. Tyrosinase is a copper catalyzed enzyme which can be activated by UV induces oxidative stress amongst others. UV induced oxidative stress leading to unbridled production of free radicals increases the activity of enzymes such as elastase, collagenase and hyaluronidase. The intervention at the stage of arresting the enzyme synthesis and activity (at the genomic and the proteomic level), is essential in controlling the progress of premature skin aging, loss of elasticity, tone, loss of suppleness, inflammation, itch or irritation (pg. 2-3, Background of Invention). Geetha et al. teach that it is an objective of the invention to disclose the process for preparing compositions of DBP for metalloprotease inhibition activity particularly collagenase, hyaluronidase, broad spectrum UV protection property due to its longer critical wavelength (pg. 3, Objective of the Invention). Geetha et al. teach that the compositions comprising DBP is useful as specific depigmenting and complexion boosting agent especially affecting tyrosinase inhibition. The compositions are also useful as effective metalloprotease inhibitors against collagenase and hyaluronidase (Summary of Invention). Geetha et al. teach that pure oxygenated DBP, particularly urolithin A (3,8-dihydroxy dibenzo-alpha pyrone) and its cogeners, have excellent ability to inhibit the enzyme tyrosinase, as well as excellent inhibitors of elastase, collagenase and hyaluronidase (pg. 4; Table 1; Claims 4-5).
Therefore, it would have been prima facie obvious for a person having ordinary skill in the art prior to the effective filing date of the instant claims to topically administer an effective concentration of the benzo[c]chromen-6-one derivatives, such as urolithin A, for the treatment of skin inflammation or skin irritation caused by sunlight or UV radiation. Such would have been obvious because Geetha et al. teach 3,8-dihydroxy-dibenzo-alpha-pyrone (Str. 1, urolithin A) as a suitable benzo[c]chromen-6-one derivative that would be suitable for treatment of skin inflammation and skin irritation and providing broad spectrum UV protection due to its longer critical wavelength (pg. 3, para. 1; pg. pg. 4, para. 3, Detailed Description; Tables 1, 2, 4, 5). Also, Geetha et al. teach the inhibition of metalloprotease activity, which is a cause of skin inflammation and irritation resulting from UV radiation.
Geetha et al. do not explicitly disclose the compositions in the form of a skin cream comprising a lipid, a mono-, di- and/or triglyceride, and at least one excipient, as instantly claimed. However, Geetha et al. teach that the compositions can be administered topically and may be in the form of w/o or o/w emulsions, self-emulsifying preparations, ointments, gels, lotions, liquids, transdermal preparations amongst others (Abstract; pg. 8-9, Cosmetic Compositions, Methods 2-4; Claims 6-8).
Nakajima teaches urolithin containing compositions as cosmetic formulations for topical application to the skin. The formulations may be in the form of a cream further comprising a lipid, glycerides and additional excipients ([0004], [0019], [0040], [0043], [0052]-[0076]). Nakajima teaches that urolithins are substances that exert effects such as anti-oxidation, anti-inflammation, and anti-saccharification, and can be expected to be effective for prevention of aging and wrinkles of the skin, whitening of the skin, and prevention of symptoms such as metabolic syndrome and diabetes ([0018]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare skin cream formulations comprising urolithin A, a lipid, a glyceride (e.g., mono-, di- and/or tri-glycerides), and at least one excipient. Such would have been obvious because Geetha et al. teach that the formulations may be in various topical forms and Nakajima teaches topical creams comprising urolithin A and excipients, such as lipids, glycerides, and other excipients. It would have been obvious to prepare known topical forms for delivery of urolithin A to the skin.
Regarding instant claims 30-31 and 36-38, Geetha et al. teach that the composition comprises 0.001-5%, preferably 0.1-1% of the benzo[c]chromen-6-one derivatives (Claim 4). See also Methods 1-4.
Regarding instant claims 32 and 39, Geetha et al. teach that the composition comprises excipients and may be in the form of emulsions, ointments, gels, lotions, liquids, etc. (Methods 1-4; Claim 8), and that the compositions may be a sunscreen composition (Method 4).
Nakajima teaches that in cases where the aqueous solution is used as a material of a cosmetic, a variety of known components that are commonly used for cosmetics may be included depending on the purpose. Examples of such components that may be included include surfactants, lower alcohols, and polyols ([0055]). Nakajima also teaches that known components that are commonly used for cosmetics may be further added as appropriate, including fat/oil components such as lauric acid ([0070]).
Regarding the skin penetration enhancers, the instant specification states, “Examples of skin penetration enhancers include sulfoxides (such as DMSO), pyrrolidones, terpenes, fatty acids, alcohols, glycols, glycol ethers and glycerides.” (pg. 23, ln. 13-16).
Nakajima teaches that the cosmetic formulations may comprise lower alcohols (0055), fatty acids ([0065], [0070]), glycols and glycol ethers ([0059]), glycerides ([0070]), etc.
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare skin cream formulations comprising an organic solvent, a skin penetration enhancer, and a medium chain triglyceride, as suggested by Nakajima. Such would have been obvious because Geetha et al. teach that the formulations may be in various topical forms and teach examples of topical gels and lotions comprising urolithin A and excipients. Nakajima teaches topical creams comprising urolithin A and excipients, such as lower alcohols, fatty acids, glycols, glycol ethers, glycerides, etc. It would have been obvious to prepare known skin cream formulations for delivery of urolithin A to the skin.
Regarding instant claims 33-34 and 40-42, Geetha et al. teach that benzo[c]chromen-6-one derivatives are suitable for topical treatment of inflammation and irritation of the skin, as well as for skin lightening, luminosity boosting, blemish control, depigmentation alleviating age spots, freckles, stretch marks, kheloid pigmentation, dark circle removal, amongst others (pg. 3, para. 1-2; pg. 4, para. 3, Detailed Description; Claim 4).
Claims 29-34 and 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Kawaguchi et al. (JP 2017-19725 A) in view of Nakajima (US 2019/0040031 A1).
Regarding claims 29-31, 33-34 and 36-38, Kawaguchi et al. teach a whitening agent comprising a melanin production inhibitor including urolithin A ([0009]-[0013], [0015], [0017], [0033]-[0035]; Claims 1-4). Kawaguchi et al. teach that the urolithin A may be used alone or may contain excipients, including an absorption promoter, solvent, surfactant, etc. ([0035], [0037], [0043]). The urolithin is present in the composition in an amount of 0.00001-10 mass%, preferably 0.0001-3% by weight, more preferably 0.003 to 1% by weight ([0036], [0038], [0042]). When used as a raw material for cosmetics, the composition can be prepared in the form of a cream ([0040], [0062]-[0065]).
Kawaguchi et al. specifically teach an example wherein a cosmetic cream comprising urolithin A, ethanol, glycerin, water, squalane, bees wax, refined jojoba oil, glycerol monostearate and polyoxyethylene (20) sorbitan monostearate is applied to the skin surface of the upper arm, UV was irradiated onto the test site, and the degree of tanning was compared ([0064]).
Kawaguchi et al. do not explicitly disclose the skin cream composition comprising about 1% to about 2% w/w urolithin A, as instantly claimed.
However, Kawaguchi et al. teach that the cosmetic compositions may comprise 0.00001-10% by weight, preferably 0.0001-3% by weight, more preferably 0.003 to 1% by weight of urolithin A ([0036], [0038], [0042]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a skin cream composition according to Kawaguchi et al. comprising about 1% to about 2% by weight of urolithin A. 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(I).
Regarding instant claims 32 and 39, Kawaguchi et al. teach that the composition may be in the form of a skin cream and comprises known components, such as emulsifiers, stabilizers, thickeners, enzymes, preservatives, lubricants, surfactants, disintegrants, disintegration inhibitors, binders, absorption promoters, adsorbents, moisturizers, solubilizers, preservatives, and the like can be blended as necessary within a range that does not impair the effects of the present embodiment ([0037], [0043]).
Nakajima teaches that in cases where the aqueous solution is used as a material of a cosmetic, a variety of known components that are commonly used for cosmetics may be included depending on the purpose. Examples of such components that may be included include surfactants, lower alcohols, and polyols ([0055]). Nakajima also teaches that known components that are commonly used for cosmetics may be further added as appropriate, including fat/oil components such as lauric acid ([0070]).
Regarding the skin penetration enhancers, the instant specification states, “Examples of skin penetration enhancers include sulfoxides (such as DMSO), pyrrolidones, terpenes, fatty acids, alcohols, glycols, glycol ethers and glycerides.” (pg. 23, ln. 13-16).
Nakajima teaches that the cosmetic formulations may comprise lower alcohols (0055), fatty acids ([0065], [0070]), glycols and glycol ethers ([0059]), glycerides ([0070]), etc.
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to prepare skin cream formulations comprising an organic solvent, a skin penetration enhancer, and a medium chain triglyceride, as suggested by Nakajima. Such would have been obvious because Kawaguchi et al. teach that the formulations may be in the form of topical skin creams comprising urolithin A and excipients. Nakajima teaches topical creams comprising urolithin A and excipients, such as lower alcohols, fatty acids, glycols, glycol ethers, glycerides, etc. It would have been obvious to prepare known skin cream formulations for delivery of urolithin A to the skin.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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/N.W.S/Examiner, Art Unit 1616
/MONICA A SHIN/Primary Examiner, Art Unit 1616
