DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Receipt of Remarks/Amendments filed on 05/19/2026 is acknowledged. Claims 1-2 and 10-11 are amended and claim 7 is canceled. Claim 12 is new. Claims 1-6 and 8-12 are currently pending and are examined on the merits herein.
Priority
The instant application filed 12/21/2023, is a 371 filing of PCT/JP2022/027175, filed 07/08/2022, which claims foreign priority to JP2021-120922, filed 07/21/2021.
Withdrawn Objections/Rejections
Claim 2 was rejected under 35 U.S.C. 112(b) as being indefinite. Applicant’s amendment to claim 2 has overcome the rejection and the rejection is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasuno, R., et al. (US 20060263399 A1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanyu, N., et al. (US 20110003838 A1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haga, M., et al. (US 20170209522 A1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee, J.W., et al. (KR 101737446 B1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsuo, A., et al. (US 20130156831 A1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fukunishi, H., et al. (US 20130109878 A1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takeoka, E., et al. (JP 2010189351 A). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-9 and 11 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Omuro, T., et al. (US 20080299068 A1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claims 1-11 were rejected under 35 U.S.C. 103 as being unpatentable over Yasuno, R., et al. (US 20060263399 A1). In view of Applicant’s amendments to the claims and upon further consideration, the rejection is overcome and is withdrawn.
Claim Interpretation
Claim 11 defines a product-by-process. The product which results from the recited process results in a product that comprises all of the same components as defined in the product of claim 1. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, the product resulting from the process defined in claim 11 is substantially the same as the product defined in claim 1 and will be examined as such.
The following grounds of rejection are necessitated by amendment:
Claim Rejections - 35 USC § 102
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.
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 1-6, 8, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lubrano, C., et al. (FR 3046352 A1, Espacenet translation used, 07/07/2021, on record), hereinafter Lubrano, as evidenced by the National Center for Biotechnology Information (2026). PubChem Compound Summary for CID 247, Betaine (on record), hereinafter NCBI, and Khurana, RK, et al. (2017). Exploring and validating physicochemical properties of mangiferin through GastroPlus® software. Future Sci OA. 3(1) (on record), hereinafter Khurana.
Lubrano discloses the cosmetic use of a eutectic solvent to improve the appearance of skin and a cosmetic composition comprising at least one eutectic solvent ([0001]).
Regarding claim 1: Lubrano teaches a cosmetic formulation comprising a low molecular weight betaine (i.e., betaine); a multivalent alcohol (i.e., glycerin); a skin condition improving ingredient (mangiferin in the form of Aphloia theiformis leaf extract); and water (p. 15, Example 8). Betaine, as taught in the examples of Lubrano, is also known as trimethyl glycine as evidenced by the NCBI. Mangiferin is extracted from the leaf of Aphloia theiformis (p. 10, para. 2), and is an active ingredient which is applied to skin for its various cosmetic effects such as "softening the skin", "improving skin tone", and "improving the hydration of the epidermis" (p. 7, para. 3). The eutectic solvent mixture comprises glycerin/betaine/water (p. 6, para. 2, Example 1; claim 8), which reads on a deep eutectic solvent formed by a complex of the low molecular weight betaine and the multivalent alcohol.
Regarding claim 2: The cosmetic formulation of Lubrano comprises glycerin.
Regarding claims 3 and 4: Betaine, also known as trimethyl glycine (NCBI), reads on the instantly claimed low molecular weight betaine and its structure, as evidenced by the instant specification (p. 7 of spec.).
Regarding claim 5: Lubrano teaches forming a eutectic solvent mixture which is used in the final cosmetic formulation. The "glycerin / betaine / water" eutectic solvent mixture is prepared at the molar ratio 2/1/1 (p. 6, para. 2, Example 1; claim 8). Thus, the molar ratio of betaine (i.e., component A) to glycerin (i.e., component B) in the final cosmetic formulation is 1/2 or 0.5, which falls within the instantly claimed range.
Regarding claim 6: The cosmetic formulation incorporates betaine (i.e., component A) at 3.132% and glycerin (i.e., component B) at 1.154%. The total of the two is 4.286%, which falls within the instantly claimed range.
Regarding claim 8: The logP of mangiferin (i.e., component C) is -0.59, as evidenced by the Khurana, which falls within the instantly claimed range.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Regarding claim 12: Since the composition anticipated by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Claims 1, 3-6, 8, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inaoka, S., et al. (US 20060030621 A1, 02/09/2006, IDS dated 12/21/2023), hereinafter Inaoka.
Inaoka teaches preparation for external use on skin in which the percutaneous absorption amount of ascorbic acid or an ascorbic acid derivative is increased and an effect on improving skin pigmentation and dullness is enhanced (abstract).
Regarding claim 1: Examples 1 and 2 of Inaoka comprise a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., diglycerol); a skin condition improving ingredient (i.e., L-ascorbic acid); and water (p. 5, Table 1). While Inaoka does not explicitly teach the formation of a deep eutectic solvent or ionic liquid, test results from the examples of Inaoka confirmed that, in the case of combining diglycerol and trimethylglycine, the permeation amount of ascorbic acid, namely, percutaneous absorption amount thereof was increased. The preparation for external use on skin comprising ascorbic acid together with diglycerol and trimethylglycine can deliver ascorbic acid into the skin more; thus, an effect that ascorbic acid possesses can be sufficiently exhibited ([0045]). Such a teaching indicates that a complex forms between the diglycerol and trimethylglycine which allows the skin condition improving agent to have improved penetration. Given that the composition of Inaoka achieves the same technical effect as that of the instant invention, and comprises all of the same ingredients at the same amounts (see claims 5 and 6 below), it is believed that the cosmetic of Inaoka inherently includes a deep eutectic solvent or ionic liquid formed by a complex of the low-molecular-weight betaine and the multivalent alcohol. When the composition anticipated by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claims 3 and 4: The low molecular weight betaine is trimethyl glycine (Examples; claim 2). Trimethyl glycine reads on the instantly claimed low molecular weight betaine and its structure, as evidenced by the instant specification (p. 7 of spec.).
Regarding claim 5: Example 1 comprises 5% of trimethyl glycine and 5% of diglycerol while Example 2 comprises 2% of trimethyl glycine and 10% diglycerol. Both examples provide a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: Example 1 comprises trimethyl glycine and diglycerol at a total amount of 10% and Example 2 at a total amount of 12%, both of which fall within the instantly claimed range.
Regarding claim 8: The logP of ascorbic acid (i.e., component C) is -1.6, as evidenced by the instant specification (p. 13, line 18 of spec.), which falls within the instantly claimed range.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Regarding claim 12: Since the composition anticipated by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
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 (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.
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 1-6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lubrano, C., et al. (FR 3046352 A1, Espacenet translation used, 07/07/2021, on record), hereinafter Lubrano, in view of Yasuno, R., et al. (US 20060263399 A1, 11/23/2006, on record), hereinafter Yasuno.
The teachings of Lubrano are discussed above.
Lubrano teaches its cosmetic formulation to improve the appearance of the skin (abstract). Skin appearance improvement can be an improvement of at least one skin surface characteristic chosen from radiance, smoothness, softness, evenness of color and tone, and/or a prevention of the degradation of at least one of these characteristics (p. 7, para. 2).
Lubrano further teaches a method of preparing a eutectic solvent mixture by solubilizing 147g of betaine in a mixture composed of 230g of glycerin and 23g of demineralized water using a propeller stirrer (p. 12, Example 1). This step reads on mixing a low molecular weight betaine with a multivalent alcohol to obtain a complex, in the absence of the skin condition improving ingredient, as partially defined in claim 10. Lubrano then teaches that 0.1% of mangiferin (syn. aphloiol) is incorporated into the mixture (p. 12, Example 1). This step reads on adding a skin condition improving ingredient to the complex, as defined in claim 10. Lastly, Lubrano teaches a cosmetic formulation incorporating the base formulation above. Such a cosmetic formulation comprises water at 75.457%, in addition to the small amount of flower water used in the above eutectic solvent mixture (p. 15, Example 8). As such, “incorporating” the above base formulation into a final cosmetic formulation comprising water reads on the instantly claimed step of subsequently adding water in claim 10.
Lubrano also teaches that the eutectic solvent comprises at least one element chosen from a simple carbohydrate, an organic acid, a polyol (i.e., glycerin), and a nitrogen compound (i.e., betaine) (p. 5, para. 3). Lubrano then teaches that the eutectic solvent may also include a small amount of water. The small amount of water is sufficient to decrease the viscosity of the cosmetic formulation base (p. 5, para. 3).
The teachings of Lubrano differ from those of the instant invention in that Lubrano does not explicitly disclose a skin condition improving ingredient of claim 9, nor mixing only the low molecular weight betaine and multivalent alcohol in the absence of water, as recited in claim 10.
Yasuno teaches preparations for external use on skin in which a water-soluble ascorbic acid can be stably dissolved by blending a low molecular weight betaine, a water-soluble ascorbic acid, and a glycol ether or a specific polyhydric alcohol. The preparations provide a moisturizing sensation and provide good fitness to the skin (abstract). In view of high safety with respect to the skin or mucosa and increased effects, L-ascorbic acid, L-ascorbyl monophosphoric esters, and L-ascorbyl-2-glucoside are particularly preferred actives ([0021]). Example 9 discloses a preparation comprising ascorbyl-2 glucoside, trimethyl glycine, diglycerol, and water ([0096], Ex. 9). L-ascorbyl-2 glucoside reads on the L-ascorbic acid glucoside of claim 9.
Regarding claim 9, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instant invention, to incorporate the ascorbyl-2 glucoside of Yasuno into the composition of Lubruno since such an ingredient is a known and routine cosmetic active in the art as taught by Yasuno. Both Lubruno and Yasuno teach formulations for stably solubilizing a cosmetic active by blending it with betaine (i.e., trimethyl glycine) and a multivalent alcohol (i.e., glycerin or diglycerol). Furthermore, both references teach their compositions as external cosmetic preparations for improving skin condition. As such, it would have been obvious to one of ordinary skill in the art to add the ascorbyl-2 glucoside of Yasuno into the cosmetic formulation of Lubruno in order to predictable generate a composition that stably solubilizes the active ingredient for improving skin condition. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One of ordinary skill in the art would have had a reasonable expectation of success in making the above modification since both actives (i.e., mangiferin and ascorbyl-2 glucoside) are solubilized by a low molecular betaine and a multivalent alcohol in skin improving compositions.
Regarding claim 10, the only difference between the process as claimed and that of Lubrano is that the instantly claimed process defines the first mixing step in the absence of water while Lubrano teaches that small amounts of water are included. However, given Lubrano’s teaching that water is only added in small amounts to the eutectic solvent in order to decrease the viscosity, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add this portion of water at any point in the method, without affecting the eutectic nature of the solvent. Adjusting viscosity with water could have been done after the step of adding in the skin condition improving agent to result in substantially the same product. Generally, the selection of any order of mixing ingredients is prima facie obvious. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930). One of ordinary skill in the art could have excluded the water of Lubrano from the initial blending step, and added the water following the addition of the skin condition improving agent to predictably generate the same final product. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since water is not an essential component of forming the eutectic of Lubrano.
Response to Arguments
Applicant's arguments filed 05/19/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that deep eutectic solvents and ionic liquids are specific complexes formed by a complex of (A) and (B), which are structurally and functionally distinct form simple aqueous solutions in which the components are merely dissolved. Applicant asserts that Lubrano teaches an aqueous solution system in which water is present during the mixing process, as such Lubrano does not disclose or suggest that a deep eutectic solvent or ionic liquid is formed by a complex of only the low molecular weight betaine and the multivalent alcohol, nor does Lubrano disclose or suggest that such a complex exists independently prior to water addition.
Examiner agrees in part with Applicant’s first point of eutectics being structurally and functionally distinct from simple aqueous solutions. As such, a majority of the 102 rejections, which simply taught aqueous solutions containing components (A) and (B) with no defined technical effect, are withdrawn. However, Lubrano explicitly teaches a eutectic solvent comprising components (A) and (B) and Inaoka explicitly taches that when (A) and (B) are formulated together that they achieve the same technical effect as instantly claimed. As such, these rejections are maintained above. In regards to Applicant’s arguments against Lubrano, it is noted that instant claim 1 recites a deep eutectic solvent or ionic liquid, each formed by a complex of (A) and (B). Water is not explicitly excluded from the complex of claim 1 nor does the claim recite closed language which prohibits additional ingredients. As such, the eutectic solvent of Lubrano, which in a specific example comprises a mixture of glycerin, betaine and water, reads on the complex as instantly claimed. Secondly, Lubrano does suggest that such a complex exists independently prior to water addition. Prior to teaching a specific eutectic mixture of glycerin, betaine, and water Lubrano teaches that the eutectic solvent primarily comprises at least one element chosen from a simple carbohydrate, an organic acid, a polyol (i.e., glycerin), and a nitrogen compound (i.e., betaine) (p. 5, para. 3). Lubrano then teaches that the eutectic solvent may also include a small amount of water. The small amount of water is sufficient to decrease the viscosity of the cosmetic formulation base (p. 5, para. 3). As such, it does not appear that the water is necessary for forming the actual eutectic but rather it is added in small amounts to modulate the viscosity. As such, it would have been obvious to one of ordinary skill in the art to form the eutectic mixture of just the betaine and the glycerin first, and then add in water at any stage to adjust viscosity.
(2) Applicant argues that independent claims 10 and 11 define mixing only (A) and (B) without the skin condition improving agent and water, and that water is only added after formation of the complex. In contrast, Lubrano teaches simultaneous mixing of betaine, glycerin and water.
In response to this argument, Examiner points to the obviousness rejection above. As previously discussed, Lubrano teaches that the eutectic solvent may include a small amount of water in order to decrease the viscosity. As such, it does not appear that the water is necessary for forming the actual eutectic but rather it is added in small amounts to modulate the viscosity. As such, it would have been obvious to one of ordinary skill in the art to form the complex first and adjust the viscosity after via the addition of water, as claimed, with no difference in the formation of the eutectic complex. Generally, the selection of any order of mixing ingredients is prima facie obvious. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930). Furthermore, Applicant has not provided any distinct evidence on the record that there is a specific structural or technical difference that results from the inclusion or exclusion of water in the complexing step. As such, a prima facie case exists for claim 10 and there is no reason to believe that the product-by-process defined in claim 11 would be structurally different than the product taught by Lubrano or Inaoka.
Conclusion
No claims 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 SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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