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 .
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 Status
Applicant’s amendment of 04/08/2026 is acknowledged. Claims 1-3, 5-10, 12, and 14 are amended; claims 4 and 15 remain cancelled; and claims 16-18 are new. Claims 1-3,5-14 and 16-18 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/EP2021/053405 filed on 02/12/2021 as
reflected in the filing receipt dated on 01/30/2024.
Previous Rejections/Objections
Applicant’s arguments filed 04/08/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied as necessitated by Applicant’s amendment to the claims. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Applicant’s arguments insofar as they pertain to the present grounds of rejections and/or objections are addressed herein.
Claim Objections
Claims 1, 7, 12, and 14 are objected to because of the following informalities:
Claims 1, 7, and 14 recite the terms “Cyclohexadec-8-en-on” and “Homomenthyl”, which are inappropriately capitalized. The terms should read “cyclohexadec-8-en-on” and “homomenthyl”.
Claim 12 recites the limitation “alpha hydroxy acids (AHA) acids”, wherein the second recitation of the term “acids” is redundant and should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-3, 5-6, 14, and 16-18 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.
Claim 1 recites “wherein the one or more agonists comprise (i) a molecular weight…and (ii) and evaporation rate…”. In the case that more than one agonist is present, it is unclear whether these properties are required of each individual agonist or of the combination of agonists. Therefore, the scope of the claim is indefinite. For the purposes of compact prosecution, the Examiner is interpreting these limitations as required of each agonist individually, as supported by the chemical structures of Applicant’s claimed agonists, which each correspond to a compound with a molecular weight that lies within the claimed range, whereas combinations of agonists would exceed the claimed range. Claims 2-3, 5-6, and 16 are rejected by virtue of their dependency on claim 1, as they fail to resolve the ambiguity in question.
Claims 5 and 6 each recite “wherein they are present”. However, claims 5 and 6 depend from claim 1, which does not require more than one agonist. Therefore, it is unclear whether claims 5 and 6 now require more than one agonist, or whether only one agonist is required. For the purposes of compact prosecution and consistent with Applicant’s instant specification which test only one agonist at a time at a concentration in the range of 0.1 to 100 µg/ml [pg. 43-44, table 1], the Examiner is interpreting the claim to mean that “they” refers to the collective limitation “one or more agonists” recited in claim 1, which includes embodiments comprising only one agonist. As such, the Examiner is interpreting the concentration to mean the total concentration of the “one or more agonists” administered must fall within the recited range.
Claim 14 recites the limitation “providing one or more agonists”, which does not require more than one agonist, followed by the limitation “applying the agonists or a composition comprising them”. The claim is rejected for similar reasons as applied to claims 5 and 6 above, as the plural recitation “the agonists” and “them” in the application step makes it unclear whether more than one agonist is required. Claim 18 is rejected by virtue of its dependency on claim 14, as it fails to resolve the ambiguity in question.
Claim 17 recites the limitations “The method of claim 7” and “providing cyclogalbanate”, which is an active method step. However, parent claim 7 is drawn to a product. The claim is indefinite because (1) the limitations lack proper antecedent basis, as it is unclear to which method the claim refers, and (2) the claim is directed to more than one statutory class of invention. Note: MPEP 2173.05(p)(II). A single claim which claims both an apparatus (or product) and the method steps of using the apparatus (or product) is indefinite because it creates confusion as to when direct infringement occurs. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011).
Response to Arguments
Applicant’s arguments submitted on 04/08/2026 with respect to rejections under 35 U.S.C. 112(b) have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that the amended claim language in claim 1 clarifies that each of the agonists has a specific molecular weight and evaporation rate. This argument was not found to be persuasive. While it is understood that each agonist necessarily has its own molecular weight and evaporation rate, the issue of indefiniteness is not resolved by the instant claim language, which states that “the one or more agonists comprise” the recited properties. The claim language makes it unclear whether the claimed properties apply to the mixture of agonists when more than one agonist is present, since the claim could be interpreted to mean that the agonists collectively comprise the claimed properties, or whether each agonist in the mixture is required to independently have the claimed properties. Therefore, the scope of the claim remains indefinite and the rejection is maintained.
Claim Rejections - 35 USC § 112(a)
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.
New Matter Rejection
Claims 1-3, 5-6, and 16 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 limitation “A method…comprising administering one or more agonists…” has been added to claim 1 in the amendment filed on 04/08/2026. However, the instant disclosure does not provide support for the breadth of the scope encompassed by the genus “administering” as recited in the amended claims. In particular, the instant specification and claims as originally filed only provide support for applying the one or more agonists topically to the skin but do not explicitly or implicitly provide support for all routes of administration such as parenteral, ocular, etc. Note: MPEP 2163. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). In this case, routes of administration (e.g., topical, parenteral, ocular, etc.) vary substantially and thus not all are supported by disclosing a method of topical application to the skin.
If Applicant believes this rejection is in error, Applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, claim 1 represents new matter, and claims 2-3, 5-6, and 16 are rejected by virtue of their dependency on claim 1.
Scope of Enablement Rejection
Claims 1-3, 5-6, and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating hyperpigmentation, does not reasonably provide enablement for preventing hyperpigmentation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
MPEP. § 2164.01(a); In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993).
The breadth of the claims
The claims are broad in that they encompass administration of one or more agonists selected from the group consisting of aldehyde C12, allylphenoxyacetate, benzyl acetone, Claritone (2,4,4,7-tetramethyloct-6-en-one, CAS No. 74338-72-0), cyclohexylmagnol, Globanone ((cis/trans) cyclohexandec-8-en-1-on, CAS No. 3100-36-5), Mintonat (homomenthyl acetate, CAS No. 67859-96-5), phenyl acetaldehyde dimethyl acetal, 4-(3-methylbutyl)cyclohexan-1-ol (CAS No. 830322-14-0), and mixtures thereof to prevent and/or treat hyperpigmentation of human skin.
The instant specification provides no definition of “preventing”. In absence of a limiting definition by Applicant, “preventing” is interpreted as defined according to the Association for Medical Education in Europe [AMEE, pg. 16-17, “Prevention”; published: 2003]. AMEE defines “preventing” as promoting health, preserving health, and restoring health when it is impaired, and minimizing suffering and distress [pg. 16, “Prevention”]. AMEE states that “primary prevention refers to the protection of health by personal and community wide effects, such as preserving good nutritional status, physical fitness, and emotional well-being, immunizing against infectious diseases, and making the environment safe.” AMEE states that “secondary prevention can be defined as the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health”. AMEE further states that “tertiary prevention consists of the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health”.
Thus, in its broadest reasonable interpretation, the prevention of a condition suggests that that the onset of the condition, in this case, hyperpigmentation, never occurs and the patient’s health is protected and preserved.
The nature of the invention
The invention is specifically directed to a method for preventing and/or treating hyperpigmentation of human skin by administering one or more of the above agonists, which Applicant’s instant specification teaches as inhibitors of tyrosinase activity [0023].
State of the prior art and (E) The level of predictability in the art
The state of the art around the time of the effective filing date of the claimed invention does not disclose a predictable method for determining the susceptibility of an individual to skin hyperpigmentation, and the art does not support that tyrosinase inhibition alone is sufficient to prevent the onset of the condition. Instead, the art suggests that several factors contribute to an individual’s proneness to developing hyperpigmentation, making its prevention unpredictable.
For example, Women’s Health teaches that factors such as skin type (e.g., amount of active pigment-producing cells), gender, genetics, hormonal fluctuations caused by pregnancy or contraception, and sun exposure contribute to melasma, which is a specific type of hyperpigmentation, and notes that sunscreen is required to prevent against melasma [Women’s Health, pg. 2-3 and 5; published: 10/13/2020]. Further, Arrowitz teaches that not all tyrosinase inhibitors are equally efficacious and supports that sunscreen is also required to prevent against melasma [Investig. Dermatol., vol. 139, pg. 1695; published: 05/10/2019]. These teachings suggest that targeting tyrosine activity alone does not predictably prevent hyperpigmentation. This is further supported by Anokha, which teaches that protection from UV exposure is critical to preventing activation of melanocytes, noting that without the use of sunscreen, skin brighteners such as those comprising tyrosinase inhibitors will be worthless [Anokha, pg. 3; published: 02/05/2018].
The references collectively highlight the complexity associated with predicting the development of skin hyperpigmentation and demonstrate that factors that influence an individual’s susceptibility to the condition, especially genetic or environmental factors, are specific to the individual and not easily predictable. Further, the state of the art suggests that tyrosinase inhibition alone is not sufficient to predictably prevent hyperpigmentation. Because one of ordinary skill in the art could not predictably determine that administering one or more of the claimed agonists by any administration route, at any dosage, and to any subject would prevent skin hyperpigmentation based on the state of the art around the time of the present invention, the full scope of independent claim 1 is not supported by the instant specification.
The level of one of ordinary skill
A person skilled in the art would include one that has advanced training in the art of pharmaceutical sciences, dermatology, and/or cosmetic science, likely a Ph.D.
The amount of direction provided by inventor and (G) The existence of working examples
Examples 1 to 24 of Applicant’s instant specification demonstrate that compounds within the scope of the instant invention reduce tyrosinase activity to some extent, wherein efficacy varies in an unpredictable manner across different concentrations [0086-0087, table 1]. Because tyrosinase inhibition is known in the art to be an effective technique for treating skin hyperpigmentation, one of ordinary skill in the art would reasonably expect that administration of one or more of the claimed agonists to the skin of a subject diagnosed with hyperpigmentation would result in treatment of the condition to at least some degree.
However, the instant specification does not expressly evaluate the ability of the claimed agonists to prevent hyperpigmentation, nor does it provide a standard by which to determine that a subject would predictably have developed the condition without having been administered one or more of the claimed agonists. Thus, the disclosure cannot ascertain the prevention of hyperpigmentation as a result of administering one or more of the claimed agonists, especially when administered through any administration route, at any dosage, and to any subject.
Extending these results to claim that the agonists prevent skin hyperpigmentation without sufficient direction does not reasonably provide enablement for a person of skill in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with the claimed method.
An analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. See MPEP 2164.01.
The working examples in Applicant's specification are reasonably enabling for a method of treating hyperpigmentation of human skin. However, the specification does contain sufficient information regarding the full scope of the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure
While the working examples in Applicant's specification are reasonably enabling for a method of treating hyperpigmentation of human skin, the specification only provides specific guidance with respect to evaluating tyrosinase activity upon treatment with the claimed agonists and does not contain sufficient information, so as to enable one skilled in the pertinent art, to make and use the full scope of the claimed invention. With this lack of sufficient information, and in view of balancing the above discussed factors, a prima facie case of undue experimentation is established.
Consider Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1161 (Fed. Cir. 2019). In Idenix, the claims recited a method of treating HCV (in this opinion one disease) by administering a broad genus of nucleoside compounds having a specific chemical structure. Idenix, 941 F.3d at 1154. The Indenix court found that the only working examples were exceedingly narrow relative to the claim scope. Indenix at 1161. The Idenix court found that “at least many, many thousands” of potential compounds met the structural requirements of the claims, and their synthesis was routine. Id. at 1157, 1160. Nevertheless, each of the compounds “would need to be screened in order to know whether or not they are effective against HCV.” Id. at 1162. The Idenix court stated that where “practicing the full scope of the claims would have required excessive experimentation, even if routine, the patent is invalid for lack of enablement.” Id. at 1163 (citation omitted). Thus, in view of the quantity of experimentation required (even though the techniques were routine), the lack of meaningful guidance or working examples across the full scope of the claim, and the immense breadth of screening required to determine which claimed compounds are effective against HCV, the Idenix court found undue experimentation. Id. at 1162. Furthermore, where, as here, “working examples are present but are ‘very narrow, despite the wide breadth of the claims at issue,’ this factor weighs against enablement.” Idenix Pharms. LLC v. Gilead Scis. Inc., 941 F.3d 1149, 1161 (Fed. Cir. 2019) (quoting Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1374 (Fed. Cir. 1999)).
In view of the Wands factors discussed above, a person of ordinary skill in the art
would have to engage in undue experimentation to practice the full scope of the claimed
invention. As such, instant claim 1 and its dependent claims 2-3, 5-6, and 16 were determined to not meet the enablement requirement of 35 U.S.C. 112(a).
Claim Interpretation
Regarding claims 1-3, in view of the Examiner’s interpretation that the limitation “wherein the one or more agonists comprise (i) a molecular weight…and (ii) and evaporation rate…” means that these properties are required of each agonist individually, and because the instant claim requires that “the one or more agonists” is selected from those recited in the Markush grouping, the Examiner is interpreting the recited molecular weight and evaporation rate as inherent properties of each compound recited in Applicant’s list in claim 1. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present. Note MPEP 2112.01.
Regarding the limitation “about” recited in claims 1-3, with no limiting definition of the term “about” provided in Applicant’s instant disclosure, the Examiner is interpreting the claims to mean ± 20% of the claimed range.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-12, and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Walke et al. (US20090197939A1; published: 08/06/2009) as evidenced by Chemtex USA (Safety Data Sheet, pg. 1-8; published: 10/09/2013).
Walke, throughout the reference, teaches a method of treating or preventing a skin condition comprising topically applying a composition that includes an aromatic skin-active ingredient on skin [abstract; claims]. Walke explicitly teaches that the disclosed compositions, which are exemplified in Tables 5 and 6, can be applied to the skin of a person in need of treating hyperpigmentation in order to treat hyperpigmentation [0013 and 0068].
Regarding claims 1-3 and 14: Walke further teaches that the aromatic skin-active ingredient is selected a limited list of compounds including 1-dodecanal [claims 4, 9, and 43; pg. 6, table 1], which is the same as instantly claimed agonist aldehyde C12 as evidenced by Chemtex USA [pg. 1, “Synonyms”]. Therefore, one of ordinary skill in the art could at once envisage an embodiment wherein Walke’s composition of Table 5 or 6, comprises 1-dodecanal as the aromatic skin-active ingredient and is applied to the skin of a person in need of treating hyperpigmentation. When the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990).
Under broadest reasonable interpretation, topically applying the composition to the skin is a form of administration. Therefore, the method of Walke, which provides 1-dodecanal in a composition that is applied to the skin, reads on the instantly claimed method steps of “administering” recited in claim 1 and “providing” and “applying” recited in claim 14.
It is noted that the recitation “for preventing and/or treating hyperpigmentation of human skin” in claim 1 is an intended outcome of administering the claimed agonists, and the recitations “non-therapeutic” and “for whitening human skin” in claim 14 are, respectively, an intended use of the claimed one or more agonists and an intended outcome of applying the one or more agonists. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the 1-dodecanal of Walke is capable of performing the intended use and achieving the intended outcomes when practicing the methods as claimed, and Walke teaches the exact same method steps as claimed, then the prior art method meets the claims. Note: MPEP 2111.02.
Regarding claim 7: The skin care composition of Walke meets the limitation “cosmetic composition”.
Regarding claim 8: Walke claims that the composition is an emulsion, a cream, a lotion, a solution, an anhydrous base, a gel, or an ointment [claims 6, 12, and 45]. Therefore, an ordinarily skilled artisan could at once envisage an embodiment wherein the composition is in the form of an emulsion, a cream, a lotion, or an ointment.
Regarding claims 9 and 10: Walke’s exemplary compositions further comprise water [0068, tables 5 and 6] and one further comprises propylene glycol [table 6], which read on the instantly claimed carrier.
Regarding claims 11 and 12: Walke’s exemplary composition of table 5 further comprises tocopheryl acetate (same compound as tocopherol acetate), which reads on the instantly claimed biogenic agent or antioxidant.
Response to Arguments
Applicant’s arguments submitted on 04/08/2026 with respect to rejections under 35 U.S.C. 102 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-3, 5-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Walke et al. (US20090197939A1; published: 08/06/2009), as applied to claims 1-3, 7-12, and 14 above, and as evidenced by Chemtex USA (Safety Data Sheet, pg. 1-8; published: 10/09/2013).
Walke as evidenced by Chemtex USA teaches the invention(s) of claims 1-3, 7-12, and 14 as discussed in detail above and further incorporated herein.
Walke further teaches that 0.001% aldehyde C-12 lauric (same as 1-dodecanal, see pg. 6, table 1) is sufficient to inhibit the activity of matrix metalloproteinase enzyme (MMP9) [0057, table 2; 0067].
Regarding claims 5 and 6: It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the concentration of 1-dodecanal in the composition of Walke using 0.001 wt.% as a starting point for routine optimization in order to achieve a desired inhibitory effect when applied topically to skin. Because the exemplary compositions of Walke comprise water as the solvent, an ordinarily skilled artisan would reasonably conclude that the densities of the compositions are approximately equivalent to that of water, i.e., 1 g/mL and, thus, 0.001 wt.% of 1-dodecanal corresponds to approximately 10 µg/mL (calculated by Examiner), which lies within and thus renders obvious the claimed range. An ordinarily skilled artisan would reasonably expect success because Walke teaches that its compositions may comprise at least 0.0001% or more of the skin-active ingredient by weight of the total weight of the composition depending on the desired effect of the composition or on the product into which the compositions are incorporated [0041].
It is generally noted that differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Given that applicant did not point out the criticality of the agonist(s) concentration of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. Note: MPEP 2144.05.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Walke et al. (US20090197939A1; published: 08/06/2009), as applied to claims 1-3, 5-12, and 14 above, and further in view of Guthrie et al. (Facial Plast. Surg., vol. 33, pg. 653-660; published: 06/2017) and as evidenced by Chemtex USA (Safety Data Sheet, pg. 1-8; published: 10/09/2013).
Walke as evidenced by Chemtex USA teaches the invention(s) of claims 1-3, 5-12, and 14 as discussed in detail above and further incorporated herein.
Walke further teaches its compositions can include skin bleaching and lightening agents such as hydroquinone [0051].
However, Walke does not expressly teach that the composition further comprises a skin whitening agent selected from the group consisting of kojic acid and resorcinols as recited in claim 13.
Guthrie teaches that in the past, hydroquinone was the gold standard for skin lightening; however, safety concerns have led to use of alternative agents such as kojic acid, which is available over the counter, to treat dyspigmentation [pg. 654-655, “Skin-Lightening Agents”].
Regarding claim 13: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition in the method of Walke by further including kojic acid in order to achieve a desired skin lightening effect. One of ordinary skill in the art would reasonably expect success in modifying the teachings of Walke as proposed because Guthrie teaches that skin lightening is a routine approach for treating hyperpigmentation [pg. 654-655, “Skin-Lightening Agents”], and kojic acid is a known, safe, and readily available alternative to the exemplary skin lightening agent, hydroquinone, disclosed by Walke.
Claims 1-3, 5-12, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Walke et al. (US20090197939A1; published: 08/06/2009), as applied to claims 1-3, 5-12, and 14 above, and further in view of Matsukawa et al. (JP2006169129A; published: 06/29/2006) and as evidenced by Chemtex USA (Safety Data Sheet, pg. 1-8; published: 10/09/2013), Foxon-Hill (WordPress, pg. 1-10; published: 07/13/2016), SciFinder (Information Page for JP2006169129A, pg. 1-2; accessed: 06/30/2026), Fujita et al. (WO2014112589A1; published: 07/24/2014), and Zviely (Perfumer & Flavorist, vol. 37, pg. 1-4; published: 08/2012).
Walke as evidenced by Chemtex USA teaches the invention(s) of claims 1-3, 5-12, and 14 as discussed in detail above and further incorporated herein.
Walke’s exemplary composition of table 6 further comprises shea butter [0068, table 6]. As evidenced by Foxon-Hill, shea butter is known to contain a high level of oleic acid bound as part of a triglyceride, wherein the breakdown of oleic acid leads to development of a rancid smell [pg. 1, photo; pg. 4, last para.].
However, Walke does not expressly teach that its composition further comprises cyclogalbanate as recited in claims 16-18.
Matsukawa teaches that fragrances having a green note like cyclogalvanate can be combined with cosmetic bases comprising oleic acids to effectively mask their strong and unpleasant odor by blending to provide a natural overall scent [0002-0006; claims]. Cyclogalvanate has the same chemical structure as cyclogalbanate, as documented by SciFinder [pg. 1, “Substances”] and as evidenced by Fujita [pg. 135, lines 5-6], which teaches that cyclogalvanate corresponds to allylcyclohexyloxyacetate, which is the same as cyclogalbanate as evidenced by Zviely [pg. 1, “F-4”].
Regarding claims 16-18: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Walke’s composition of Table 6, which as discussed above is applied to the skin using the method of Walke, by further including a fragrance with a green note, such as Matsukawa’s cyclogalbanate, in order to mask the unpleasant smell known to develop from the oleic acids present in shea butter. An ordinarily skilled artisan would reasonably expect success in modifying the teachings of Walke as proposed because Matsukawa teaches that this combination of ingredients is known to successfully mask cosmetic odors, and Walke recognizes that odor neutralizing compounds can be used in compositions including the disclosed aromatic skin-active ingredients [0008].
Response to Arguments
Applicant’s arguments submitted on 04/08/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-28 of copending Application No. 18/870,005 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a fragrance composition and a method of enhancing a fragrance composition, wherein the fragrance composition comprises a compound of formula I and a further fragrance, which is selected from a limited list including cyclohexylmagnol. Therefore, an ordinarily skilled artisan could at once envisage an embodiment wherein the fragrance composition recited in the copending claims includes cyclohexylmagnol, which reads on the instantly claimed one or more agonists and thus meets all limitations of the instantly claimed cosmetic or pharmaceutical composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 7 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following copending claims for substantially the same reasons as applied above in view of claims 16-28 of copending Application No. 18/870,005:
Claims 16-31 of copending Application No. 18/864,067, which recite a method of providing a fragrance composition and fragrance composition, wherein the fragrance composition comprises a fragrance selected from a limited list including the instantly claimed 2,4,4,7-tetramethyloct-6-en-3-one.
Claims 5-10 and 13-15 of copending Application No. 18/718,270, which recite a fragrance composition and a perfumed product, each comprising a fragrance selected from a limited list including the instantly claimed cyclohexylmagnol.
Claims 1-6 and 8-21 of copending Application No. 18/577,496, which recite a fragrance composition, a method comprising formulating a fragrance composition, and a method comprising providing a fragrance composition, wherein the fragrance composition comprises a compound selected from a limited list including the instantly claimed globanone.
Claim 7 and 9-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following copending claims for substantially the same reasons as applied above in view of claims 16-28 of copending Application No. 18/870,005:
Claims 1-13 of copending Application No. 18/281,339, which recite a fragrance mixture, a cosmetic preparation containing the fragrance mixture, and a perfume composition comprising the fragrance mixture, wherein the fragrance mixture comprises a component (b) selected from a limited list including the instantly claimed cyclohexadec-8-en-1-one, and wherein the perfume composition comprises at least one carrier selected from a limited list including the instantly claimed ethanol.
Claims 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following patented claims for substantially the same reasons as applied above in view of claims 16-28 of copending Application No. 18/870,005:
Claims 1-13 of U.S. Pat. No. 12,421,474 B2, which recite a perfume oil mixture and compositions comprising the perfume oil mixture, wherein the perfume oil mixture comprises a fragrance selected from a limited list including the instantly claimed globanone, and wherein the composition is an emulsion, crème, lotion, or ointment, among a limited list of others.
Claims 1-11 of U.S. Pat. No. 9,340,751 B2, which recite a method comprising mixing fragrance substances (to necessarily form a mixture), a fragrance mixture, and a perfumed product containing a fragrance mixture, wherein the fragrance mixture comprises a compound selected from a limited list including the instantly claimed cyclohexadec-8-en-1-one and the perfumed product is selected from several forms of creams and lotions (hand, foot, depilatory, after-shave, tanning), among a limited list of others.
Claim 7 and 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following patented claims for substantially the same reasons as applied above in view of claims 16-28 of copending Application No. 18/870,005:
Claims 1-7 of U.S. Pat. No. 11,344,857 B2, which recite a process for producing a microcapsule, a microcapsule, and compositions, cosmetic formulations, or perfume compositions comprising microcapsules, wherein the active ingredient is a fragrance selected from a limited list including the instantly claimed benzylacetone and can further include an essential oil, which reads on the instantly claimed biogenic agent or antioxidant.
Claims 1-16 of U.S. Pat. No. 9,631,165 B2, which recite a method for the production of washing and cleaning compositions, wherein the composition comprises fragrance capsules containing fragrances selected from a limited list including the instantly claimed 2,4,4-7-tetramethyloc-6-en-3-one and benzylacetone and can further include an essential oil, which reads on the instantly claimed biogenic agent or antioxidant.
Response to Arguments
Applicant’s arguments submitted on 04/08/2026 with respect to rejections on the grounds of non-statutory double patenting have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that US ‘165 is directed to a method for producing washing and cleaning compositions, and alleges there is no reasonable basis for rejection as the claims of US ‘165 are not related to the pending claims and there is no reasonable basis to combine US ‘165 with the other cited references.
Applicant’s argument regarding the combination of US ‘165 with the other cited references is moot because the modified ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s argument that the claims of US ‘165 are not related to the pending claims: This argument was not found to be persuasive. The method recited in the claims of US ‘165 produces a composition comprising the same ingredients as instantly claimed (e.g., 2,4,4,7-tetramethyloct-6-en-3-one and benzyl acetone), and the only difference lies in the intended uses of the compositions, wherein the claims of US ‘165 are drawn to washing and cleansing compositions and the instant claims are drawn to any cosmetic or pharmaceutical composition comprising one or more of the recited agonists. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition recited in the claims of US ‘165 is capable of performing the intended use and the composition claimed in US ‘165 contains no additional ingredients that appear to be unsafe for human skin and/or cosmetic use, then it meets the claim. Note: MPEP 2111.02.
Therefore, the Examiner maintains that the non-statutory double patenting rejections of record are proper and thus maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
Prosecution Insights