DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed on 12 February 2026, has been entered.
Status of Claims
The amendment, filed on 12 February 2026, is acknowledged.
Claims 1, 3, 15-16, 21, and 25 are amended.
Claims 3, 7-10, and 14 were previously withdrawn as being drawn to a nonelected species in the Office Action mailed on 22 May 2025.
Claims 1, 4-6, 11, 15-18, and 21-27 are pending and under consideration in the instant Office Action, to the extent of the elected species Amberketal®, structure 17 in Table 1 of the specification.
Rejections Withdrawn
Rejections pursuant to 35 U.S.C. § 112
The rejection of claim 16 under 35 U.S.C. § 112(b) maintained in the Office Action mailed on 13 November 2025, has been overcome by Applicant’s amendment to the claim. Accordingly, the rejection is withdrawn.
Maintained Rejections
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.
Claims 1, 4-6, 11, 15-18, and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Muratore et al. (European Patent No. EP 3233820 B1, published on 15 May 2019, references to English translation, hereafter referred to as Muratore) in view of Givaudan SA (Great Britain Patent Application Publication No. GB 2005468.0, published on 27 May 2020).
Muratore teaches novel acetals of general formula I which have an amber or animal note, methods of their synthesis, and their use in perfumery, cosmetics and detergents for their fragrance (pg. 2, Description). Compounds with amber or animal notes are taught to be desirable in the perfume industry but difficult and/or expensive to produce (pg. 2, Description). Examples of these compounds known in the industry are taught to include Ambrinol, Grisalva, and Amberketal® (pg. 3, first and last figures). Muratore teaches that the formula of their invention and its method of production is “simple, efficient in terms of yield, having a small number of steps, and therefore inexpensive” (pg. 3, para. 7).
Due to the pleasant odor of the compounds of formula I, Muratore teaches the compounds have applications in perfumery (pg. 4, final para.). Perfumery is used in its general sense – not just in perfumes, colognes, and similar products, but in topical cosmetic compositions such as creams for the face and/or body, shampoos, hair lotions, antiperspirants, and ointments (pg. 4, final para.). These cosmetic compositions would inherently be applied to a user’s skin or hair.
Muratore does not teach a composition comprising Amberketal®. This deficiency is offset by the teachings Givaudan SA.
Givaudan SA teaches a method of synthesizing Amberketal® and its homologues, compositions comprising Amberketal® and its homologues, and the use of consumer products comprising said compositions (page 6, Technical Field). Amberketal® is taught to possess a “powerful and tenacious ambery and woody odour that is useful in fragrance compositions” (pg. 6, lines 10-11). The typical method of synthesizing Amberketal® is taught to involve Manool, which is in limited supply and subsequently expensive, resulting in the need for a “new efficient and cost effective synthetic route to obtain Amberketal® and amberketal homologues” (pg. 6, lines 12-15). The compound is represented by Formula (I) when R=methyl and the stereoisomer of Amberketal®, (-)-epi-8-Amberketal, is represented by Formula (IV) when R=methyl (pg. 8, lines 4-22 and pg. 15, lines 11-19). Finally, Givaudan SA teaches a consumer product comprising Amberketal® and the formulation of a fragrance composition (claims 7-11).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Muratore and Givaudan SA because combining prior art elements according to known methods yields predictable results. An artisan would be motivated to combine the teachings because Muratore teaches Amberketal® to be desirable in perfumery, including products that are applied to the skin or hair such as creams, shampoos, hair lotions, and ointments. Muratore teaches that Amberketal® is difficult and expensive to produce, however, and teaches alternative compounds to be use in perfumery of the general formula I and teaches the method of applying the perfumery compositions to the skin or hair. Givaudan SA teach an alternative, inexpensive and efficient method of synthesizing Amberketal® that an artisan would be motivated to use in the invention of Muratore to reduce the difficulty and cost of manufacturing a perfumery product that would be applied to a user’s hair or skin.
Although Muratore and Givaudan SA are silent about self-tanning (claims 1 and 21), darkening of the desired skin (claims 5 and 23), and sunless tanning of the desired skin (claims 6 and 24), it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to method of Muratore and Givaudan SA, supra. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “[I]t is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). The mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See MPEP 2145(II).
Thus, because Muratore and Givaudan SA teach the identical method of applying to the skin or hair the same chemical structure of Amberketal® as a perfumery cosmetic composition, Amberketal® applied to the skin as a perfume cosmetic would necessarily be self-tanning, would necessarily darken the desired skin, and necessarily sunless tan the desired skin. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
As a result, there is a reasonable expectation of success in arriving at the invention of claims 1, 4-6, 11, 15-18, and 21-27 in view of the teachings of Muratore and Givaudan SA.
Claims 1, 4-6, 11, 15-18, and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Givaudan SA (Great Britain Patent Application Publication No. GB 2005468.0, published on 27 May 2020) in view of Gelis et al. (J. Bio. Chem. 2016, 291 (34), 17772., hereafter referred to as Gelis), Moser et al. (European Patent Application Publication No. EP 2014276 A1, published on 14 January 2009, provided by Applicant in IDS, hereafter referred to as Moser), Sell (Terpenoids. Kirk-Othmer Encyclopedia of Chemical Technology, Vol. 24. John Wiley & Sons, Inc. 2006), and Sowndhararajan et al. (Sci. Pharm. 2016, 84, 724., hereafter referred to as Sowndhararajan).
Givaudan SA teaches a method of synthesizing Amberketal® and its homologues, compositions comprising Amberketal® and its homologues, and the use of consumer products comprising said compositions (page 6, Technical Field). Amberketal® is taught to possess a “powerful and tenacious ambery and woody odour that is useful in fragrance compositions” (pg. 6, lines 10-11). The compound is represented by Formula (I) when R=methyl and the stereoisomer of Amberketal®, (-)-epi-8-Amberketal, is represented by Formula (IV) when R=methyl (pg. 8, lines 4-22 and pg. 15, lines 11-19).
The olfactive purity of Amberketal® following synthesis is taught to be important and a method of testing its purity, including comparison to commercially available references, is taught such that the purity to be used in compositions can be confirmed to be ≥80% (pg. 18, lines 8-14 and pg. 19, lines 10-13). Fragrance compositions comprising Amberketal® are taught, in addition to comprising carriers, diluents, and other ingredients commonly used in the art (pg. 22, Fragrance compositions). Finally, Givaudan SA teaches a consumer product comprising Amberketal® and formulation of a fragrance composition (claims 7-11).
Givaudan SA does not teach the impact of Amberketal® on melanin, a composition formulated as a tanning, moisturizing, or haircare composition, Amberketal® being in the chemical class of terpenoids, nor fragrant substances being perceived by humans following interaction with olfactory receptors. These deficiencies are offset by the teachings Gelis, Moser, Sell, and Sowndhararajan.
Gelis teaches the characterization of olfactory receptors, which are known to be expressed in non-sensory tissues mediating a variety of cellular functions (pg. 17772, Abstract). Olfactory receptors (ORs) are taught to be the basis of the sense of smell and originally thought to be exclusively expressed in the olfactory epithelium, though subsequent experiments found ORs expressed in non-olfactory tissues, indicating they have physiological functions outside of smell (pg. 17772, left column, para. 1). In particular, Gelis teaches that odorants were found to influence pigment cells in the 1980s in frogs (pg. 17783, Discussion, Functionality of an Ectopically Expressed Odorant Receptor in Melanocytes, para. 1). Further experiments found that cinnamaldehyde and b-ionone, a sesquiterpene, had “pigment dispersing activity in fish melanophores” (pg. 17783, Discussion, Functionality of an Ectopically Expressed Odorant Receptor in Melanocytes, para. 1). The researchers chose to test the effects of b-ionone on human ORs of family 51, subfamily E, member 2 (OR51E2), an OR that affects human “melanocyte proliferation, differentiation and melanogenesis” (pg. 17783, Discussion, Functionality of an Ectopically Expressed Odorant Receptor in Melanocytes, para. 2).
Activation of the olfactory receptor OR51E2 with b-ionone was confirmed to induce melanogenesis and impact melanocyte differentiation (pg. 17784, Discussion, Role of OR51E2 on Melanogenesis and Pigment Cell Differentiation, para. 1-3). Gelis teaches in conclusion that pigment cells respond to b-ionone with decreased proliferation rates and increased melanogenesis (pg. 17785, left column, final para.). Because OR51E2 signaling mechanisms can impact melanocyte homeostasis, Gelis suggest that steroids or terpenoids that activate the OR could be useful in treating conditions related to pigmentation (pg. 17785, left column, final para.).
Moser teaches cosmetic compositions comprising sclareolide and hesperidin methyl chalcone (HMC) which can be used for the tanning of skin, darkening of hair, and/or prevention of greying hair (Abstract). The traditional method of tanning skin is taught to be exposure to sun light, but due to the risks associated with skin exposure to UV radiation, including oxidative damage, photo-ageing, increased incidence of skin cancer, and degradation of proteins and lipids, “there is a need for agents to tan skin without the risks that are linked to exposure to UV radiation” (para. [0002]). These agents are referred to as “self-tanning” agents, are taught to work by reacting with skin proteins and/or amino acids to form brown-yellow colored substances, and examples of such agents used in the art include dihydroxyacetone, erythrulose, and lawsone (para. [0003]). However, the above examples are taught to have drawbacks including the production of an ”artificial” skin tone and lack of protection against sun radiation (para. [0003]).
To avoid the above drawbacks while achieving the goal of self-tanning, Moser teaches compositions comprising sclareolide and HMC which are known in the art to be useful in cosmetic compositions (para. [0006-0007]). Sclareolide, a terpenoid (sesquiterpene) lactone, is taught to be “a precursor to Ambroxan® [brand name of ambroxide], a valuable ambergris fragrance used in perfumery” (para. [0016]). In Examples 1 and 2, Moser teaches that sclareolide increases the rate of melanin synthesis in melanocytes without inducing cell toxicity. The compositions comprising sclareolide may be formulated as hair care compositions, creams, gels, lotions, or ointments and comprise 0.001-2.0% w/w sclareolide (para. [0018-0019]). Additionally, Moser teaches that the compositions may be used as an enhancer/stimulator of synthesis of melanin, for sunless tanning of the skin, and to homogenize skin color near pigment spots (para. [0043]).
Sell teaches a review of terpenoids, sometimes referred to as isoprenoids, which are molecules with structures made of isoprene (2-methylbuta-1,3-diene) units (pg. 1, 1.1. Definitions). Terpenoids are taught to occur in nature and play many roles, including in human metabolic processes and photosynthesis as a part of chlorophyll (pg. 2, 1.2. Biosynthesis and 1.3 Biological Significance). In section 9.2.1.3 Ambergris Analogues, Sell teaches Amberketal®, otherwise known as Jeger’s ketal after its discoverer, as a terpenoid that possesses a “powerful ambergris odor” (pg. 79, final para.).
Sowndhararajan teaches the influence of fragrances on human psychophysiological activity and the mechanisms of human perception of odors (Abstract). Fragrances are taught to be volatile chemicals, usually with a molecular weight < 300 g/mol, that “humans perceive via the olfactory system” (pg. 725, para. 2). In the process of perceiving fragrances, “fragrance stimulation of olfactory receptor cells in the nose involves interaction of fragrance molecules with olfactory-receptor proteins” (pg. 728, para. 1).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Givaudan SA and Gelis because applying a known technique to a known product ready for improvement yields predictable results. In the instant case, the known product is the fragrance composition comprising Amberketal® taught by Givaudan SA. Gelis teaches that compounds which activate olfactory receptors in human cells can impact melanocytes, including their production of melanin (melanogenesis) and proliferation. Gelis also teaches that terpenoids that activate olfactory receptors may be useful in treating pigmentation conditions because b-ionone, a sesquiterpene, demonstrated the ability to impact the production of melanin in melanocytes. The teachings of Sell and Sowndhararajan demonstrate that Amberketal® is a terpenoid and, as a fragrant molecule, would interact with olfactory receptors. It would have been obvious to an artisan to use a composition that has been formulated to be safely applied to the skin as a fragrance composition which comprises Amberketal®, a terpenoid that is taught by the art to activate olfactory receptors, to impact melanocytes.
It further would have been prima facie obvious to an artisan to modify the invention rendered obvious by the teachings of Givaudan SA, Gelis, Sell, and Sowndhararajan with the teachings of Moser to arrive at the claimed invention because simple substitution of one known element for another yields predictable results. Moser teaches compositions comprising sclareolide, a terpenoid (sesquiterpene) lactone, that enhance/stimulate melanin synthesis, tan the skin without sun, and may be applied to skin or hair. It would have been obvious to an artisan to use Amberketal® in the composition taught by Moser as a self-tanning agent because it is also a terpenoid, which are taught by Gelis to have utility in modifying melanin production, and like sclareolide is an analogue of ambroxide, so therefore is a likely candidate to impact melanocyte function. As a result, there is a reasonable expectation of success in arriving at the invention of claims 1, 4-6, 11, 15-18, and 21-27 in view of the teachings of Givaudan SA, Gelis, Moser, Sell, and Sowndhararajan.
Response to Arguments
Applicant's arguments filed 12 February 2026, have been fully considered but they are not persuasive.
In para. 2 of pg. 17, Applicant argues that they have found a novel method of self-tanning which is distinct from discovery of an unknown but inherent function of a cosmetic composition comprising Amberketal®. However, Applicant’s claimed novel method comprises application of a composition comprising Amberketal® to the skin of a user, which is prima facie obvious in view of the prior art (vide supra). Applicant is reminded that “the prior art need not disclose a newly discovered property in order for there to be a prima facie case of obviousness.” Dillon, 919 F.2d at 697, 16 USPQ2d at 1904-05. See MPEP § 2144.08(d). As a result, Applicant’s argument regarding distinction between their method and the teachings of the prior art are found unpersuasive.
In para. 3 of pg. 17, Applicant states that they have found “a different use for the same compound”. As stated in the final Office Action mailed on 13 November 2025, and repeated here for convenience, because the method of applying a composition comprising Amberketal® to the skin or hair has been rendered obvious (vide supra), and the self-tanning effect is an inherent property of the chemical structure, the method rendered obvious by the teachings of Muratore and Givaudan SA necessarily tans the desired skin without sun. If this process occurs via interaction of Amberketal® with receptor OR7C1, this is also inherent to the method rendered obvious above even if the prior art did not teach this mechanism. “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Wiseman, 201 USPQ 658 (CCPA 1979). See MPEP 2145.(II). Granting a patent on the discovery of an unknown but inherent function “would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art.” In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). Finally, finding a different use for a given compound does not render the instant method nonobvious when said method is obvious in view of the prior art and the claimed use results from an inherent property of the known compound.
In the final para. of pg. 17, Applicant states that they have surprisingly found that the recited compounds are agonists of olfactory receptor OR7C1 and can trigger production of melanin by melanocytes. Guidelines on determining whether results are expected or unexpected are provided in MPEP § 716.02. To demonstrate that results are unexpected and significant, the Applicant has the responsibility of presenting evidence that establishes “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims” (bold added for emphasis). See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e).
Applicant has not presented evidence that establishes that their results are unexpected and unobvious, nor have they compared their claimed invention with the closest prior art commensurate in scope with the claimed invention. Applicant is additionally reminded that "[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). As a result, Applicant’s arguments are not persuasive in distinguishing the claimed method from the prior art.
Applicant argues that the Muratore (para. 1 of pg. 18), Givaudan SA (para. 2 of pg. 18), Gelis, Moser, Sell, and Sowndhararajan (para. 3 of pg. 18) references do not teach Amberketal® to be an agonist of OR7C1 or its use as a method of self-tanning. Applicant is directed to the previous paragraph and reminded that identification of a property that is inherent in a known compound does not render a method of its use patentable.
New Grounds of Objection
Objection to the Specification
The use of the terms Amberketal®, Ambermax™, Norlimbanol®, Ambercore®, Belambre®, Ambroxan®, Sylvamber™, Hydroxyambran®, and Cedroxyde ® (see Table 1 and throughout the instant specification), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Conclusion
No claims are allowed.
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/S.J.S./
Examiner, Art Unit 1619
/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617