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
The preliminary amendment of 12/21/2023 is acknowledged. Claims 3-9 are amended. Claims 1-11 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
1. Claim 2 is 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 2 recites both “glycerin” and “glycerol”, however, these are different names for the same compound. It is therefore unclear how these two compounds would result in different compositions, making the claim indefinite.
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 1-8 and 10-11 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, PTO-892), hereinafter Lubrano, as evidenced by the National Center for Biotechnology Information (2026). PubChem Compound Summary for CID 247, Betaine (PTO-892), hereinafter NCBI, and Khurana, RK, et al. (2017). Exploring and validating physicochemical properties of mangiferin through GastroPlus® software. Future Sci OA. 3(1) (PTO-892), 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).
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. 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 7: It is inherent that the betaine (i.e., component A) and glycerin (i.e., component B) will form a complex when present in the same composition. 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. Furthermore, Lubrano explicitly teaches betaine and glycerin to form a eutectic mixture which reads on the instantly claimed “complex”.
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 10: Lubrano 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. Solubilization is carried out at 50°C, under low stirring (500 rpm), for 30 minutes (p. 12, Example 1). This step reads on mixing a low molecular weight betaine with a multivalent alcohol to obtain a complex, as instantly claimed. 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 instantly claimed. 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.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasuno, R., et al. (US 20060263399 A1, 11/23/2006, PTO-892), hereinafter Yasuno.
Yasuno teaches a preparation 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 (abstract).
Regarding claim 1: Yasuno teaches various preparations comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., diglycerol and/or propylene glycol); a skin condition improving ingredient (i.e., ascorbic acid, ascorbyl 2-glucoside, or sodium ascorbyl monophosphate); and water (Examples 3, 7, 9, and 13).
Regarding claim 2: The multivalent alcohol is propylene glycol and/or diglycerol. The propylene glycol (Ex. 7 and 13) reads on the instantly claimed multivalent alcohol.
Claims 3 and 4: The low molecular weight betaine is trimethyl glycine ([0009]); claim 2; Examples 3, 7, 9, and 13). 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: Examples 3 and 9 comprise 3% trimethyl glycine and 4% diglycerol. Example 7 comprises 3% trimethyl glycine and 20% propylene glycol. Example 13 comprises 3% trimethyl glycine and 20% propylene glycol + 1% diglycerol. Each example comprises (A) and (B) in amounts that result in a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: Examples 3, 7, 9, and 13 all comprise a total content of trimethyl glycine plus the multivalent alcohol within the instantly claimed range (ranging from 7% to 24% total).
Regarding claim 7: It is inherent that the trimethyl glycine and the multivalent alcohol(s) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of ascorbic acid (i.e., component C of Ex. 3 and 7) is -1.6, as evidenced by the instant specification (p. 13, line 18 of spec.), which falls within the instantly claimed range. The logP of ascorbic acid glucoside (i.e., component C of Ex. 9) is -5.9, as evidenced by the instant specification (p. 13, lines 18-19 of spec.), which falls within the instantly claimed range.
Regarding claim 9: The skin condition improving ingredient of Example 9 is ascorbyl 2-glucoside which reads on the instantly claimed L-ascorbic acid glucoside.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hanyu, N., et al. (US 20110003838 A1, 01/06/2011, IDS dated 12/21/2023), hereinafter Hanyu.
Regarding claim 1: Hanyu teaches a moisturizing lotion comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., glycerol and 1,3-butylene glycol); a skin condition improving ingredient (i.e., tranexamic acid and a pyrimidylpyrazole compound); and water (Formulation Ex. 17).
Regarding claim 2: The multivalent alcohol is glycerol and 1,3-butylene glycol.
Regarding claims 3 and 4: The betaine is trimethyl glycine which 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: Trimethyl glycine (i.e., component A) is present at 1% by mass while glycerol is present at 1% by mass and 1,3-butylene glycol at 5% (i.e., component B). Assuming a total solution weight of 100g, trimethyl glycine has a molecular weight of 117.15 g/mol, meaning it would be present at 0.0085 moles (i.e., 1g ÷ 117.15 g/mol). Glycerol has a molecular weight of 92.09 g/mol meaning it would be present at 0.0108 moles (i.e., 1g ÷ 92.09 g/mol) and 1,3-butylene glycol has a molecular weight of 90.12 g/mol meaning it would be present at 0.0555 moles (i.e., 5g ÷ 90.12 g/mol). The resulting molar ratio of (A):(B) is 0.128 (i.e., 0.0085 ÷ (0.0108 + 0.0555)), which falls within the instantly claimed range.
Regarding claim 6: The total amount of trimethyl glycine (i.e., component A), glycerol, and 1,3-butylene glycol (i.e., component B) is 7% by mass, which falls within the instantly claimed range.
Regarding claim 7: It is inherent that the trimethyl glycine (i.e., component A) with glycerol and 1,3-butylene glycol (i.e., component B) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of tranexamic acid (i.e., component C) is -2, as evidenced by the instant specification (p. 13, line 21 of spec.), which falls within the instantly claimed range. The pyrimidylpyrazole compound of Hanyu (i.e., compound of the present invention; claim 14) has a logP of 3 or less as evidenced by the instant specification (p. 14, lines 11-16 of spec.).
Regarding claim 9: The skin condition improving ingredient is tranexamic acid or a pyrimidylpyrazole, as discussed above. The pyrimidylpyrazole has the following structure:
PNG
media_image1.png
338
224
media_image1.png
Greyscale
, wherein R1, R3, R4, and R6 are each independently C1-3 alkyl; and R2 and R5 are each independently a hydrogen atom or C1-3 alkyl (claim 14).
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haga, M., et al. (US 20170209522 A1, 07/27/2017, PTO-892), hereinafter Haga.
Regarding claim 1: Haga teaches an aging care essence comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., 1,3-butylene glycol); a skin condition improving ingredient (i.e., hyaluronic acid); and water (Tables 1-13; 2-19; 3-18; 4-19).
Regarding claim 2: The multivalent alcohol is 1,3-butylene glycol.
Regarding claims 3 and 4: The betaine is trimethyl glycine which 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: Trimethyl glycine (i.e., component A) is present at 3% by weight and 1,3-butylene glycol (i.e., component B) is present at 5% by weight. Such amounts result in a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: The total amount of trimethyl glycine (i.e., component A) and 1,3-butylene glycol (i.e., component B) is 8% by weight, which falls within the instantly claimed range.
Regarding claim 7: It is inherent that the trimethyl glycine (i.e., component A) and 1,3-butylene glycol (i.e., component B) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of hyaluronic acid (i.e., component C) is -7.4, as evidenced by the instant specification (p. 14, lines 6-7 of spec.), which falls within the instantly claimed range.
Regarding claim 9: The skin condition improving ingredient is hyaluronic acid, as discussed above.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1, 3-8 and 11 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).
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 7: It is inherent that the trimethyl glycine and the diglycerol will form a complex when present in the same composition. 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.
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.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee, J.W., et al. (KR 101737446 B1, Espacenet translation used, 05/29/2017, PTO-892), hereinafter Lee.
Lee discloses a skin protecting composition which can be used continuously by general consumers and atopic patients due to excellent moisture retention by maximizing penetration into the skin (para. 10).
Regarding claim 1: Lee teaches a cream cosmetic composition comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., 1,3-butylene glycol and glycerin); a skin condition improving ingredient (i.e., hyaluronic acid); and water (p. 6, Production Ex. 1 to 5).
Regarding claim 2: The multivalent alcohol comprises 1,3-butylene glycol and glycerin (Production Examples 1 to 5).
Regarding claims 3 and 4: The betaine is trimethyl glycine which 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: Trimethyl glycine (i.e., component A) is present at 1 wt% and 1,3-butylene glycol and glycerin (i.e., component B) are present at 4 wt% each. Such amounts result in a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: The total amount of trimethyl glycine (i.e., component A) and 1,3-butylene glycol and glycerin (i.e., component B) is 9 wt%, which falls within the instantly claimed range.
Regarding claim 7: It is inherent that the trimethyl glycine (i.e., component A) with 1,3-butylene glycol and glycerin (i.e., component B) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of hyaluronic acid (i.e., component C) is -7.4, as evidenced by the instant specification (p. 14, lines 6-7 of spec.), which falls within the instantly claimed range.
Regarding claim 9: The skin condition improving ingredient is hyaluronic acid, as discussed above.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsuo, A., et al. (US 20130156831 A1, 06/20/2013, PTO-892), hereinafter Matsuo.
Regarding claim 1: Matsuo teaches a whitening milk comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., glycerin, 1,3-butylene glycol, 1,2-pentanediol, and xylitol); a skin condition improving ingredient (i.e., ascorbic acid glucoside); and water (p. 9, Formulation Ex. 6).
Regarding claim 2: The multivalent alcohol comprises glycerin, 1,3-butylene glycol, 1,2-pentanediol, and xylitol.
Regarding claims 3 and 4: The betaine is trimethyl glycine which 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: Trimethyl glycine (i.e., component A) is present at 3% by mass while glycerin is present at 7% by mass, 1,3-butylene glycol at 7%, 1,2-pentanediol at 1%, and xylitol at 3% (i.e., component B). Such amounts result in a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: The total amount of trimethyl glycine (i.e., component A), glycerin, 1,3-butylene glycol, 1,2-pentanediol, and xylitol (i.e., component B) is 21% by mass, which falls within the instantly claimed range.
Regarding claim 7: It is inherent that the trimethyl glycine (i.e., component A) with glycerin, 1,3-butylene glycol, 1,2-pentanediol, and xylitol (i.e., component B) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of ascorbic acid glucoside (i.e., component C) is -5.9, as evidenced by the instant specification (p. 13, lines 18-19 of spec.), which falls within the instantly claimed range.
Regarding claim 9: The skin condition improving ingredient is ascorbic acid glucoside, as discussed above.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fukunishi, H., et al. (US 20130109878 A1, 05/02/2013, PTO-892), hereinafter Fukunishi.
Regarding claim 1: Fukunishi teaches a skin lotion comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., glycerin and 1,3-butylene glycol); a skin condition improving ingredient (i.e., tranexamic acid); and water (p. 6; Formulation Ex. 3).
Regarding claim 2: The multivalent alcohol comprises glycerin and 1,3-butylene glycol.
Regarding claims 3 and 4: The betaine is trimethyl glycine which 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: Trimethyl glycine (i.e., component A) is present at 1% by mass while glycerin is present at 1% by mass and 1,3-butylene glycol at 5% (i.e., component B). Such amounts result in a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: The total amount of trimethyl glycine (i.e., component A), glycerin, and 1,3-butylene glycol (i.e., component B) is 7% by mass, which falls within the instantly claimed range.
Regarding claim 7: It is inherent that the trimethyl glycine (i.e., component A) with glycerin and 1,3-butylene glycol (i.e., component B) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of tranexamic acid (i.e., component C) is -2, as evidenced by the instant specification (p. 13, line 21 of spec.), which falls within the instantly claimed range.
Regarding claim 9: The skin condition improving ingredient is tranexamic acid, as discussed above.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takeoka, E., et al. (JP 2010189351 A, Espacenet translation used, 09/02/2010, PTO-892), hereinafter Takeoka.
Takeoka discloses a transdermal absorption promoting agent or a transdermal absorption control agent which allows selective and efficient permeation of only a target drug to a target part in the skin (abstract).
Regarding claim 1: Takeoka teaches a lotion and a O/W cream, both comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., glycerin, dipropylene glycol and/or erythritol); a skin condition improving ingredient (i.e., L-ascorbic acid 2-glucoside); and water (p. 8, para. 2; p. 9, para. 2).
Regarding claim 2: The multivalent alcohol comprises glycerin (lotion and O/W cream example) and/or erythritol (lotion example).
Regarding claims 3 and 4: The betaine is trimethyl glycine which 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: In the lotion example, trimethyl glycine (i.e., component A) is present at 3% by mass while glycerin is at 38% by mass, dipropylene glycol at 8%, and erythritol at 0.3% (i.e., component B). Such amounts result in a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: In the lotion example, the total amount of trimethyl glycine (i.e., component A) glycerin, dipropylene glycol and erythritol (i.e., component B) is 49.3% by mass, which falls within the instantly claimed range.
Regarding claim 7: It is inherent that the trimethyl glycine (i.e., component A) with glycerin, dipropylene glycol and/or erythritol (i.e., component B) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of ascorbic acid glucoside (i.e., component C) is -5.9, as evidenced by the instant specification (p. 13, lines 18-19 of spec.), which falls within the instantly claimed range. Regarding claim 9: The skin condition improving ingredient is L-ascorbic acid glucoside, as discussed above.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
Claims 1-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Omuro, T., et al. (US 20080299068 A1, 12/04/2008, PTO-892), hereinafter Fukunishi.
Regarding claim 1: Omuro teaches a skin care milky lotion comprising a low molecular weight betaine (i.e., trimethyl glycine); a multivalent alcohol (i.e., 1,3-butylene glycol and xylitol); a skin condition improving ingredient (i.e., tranexamic acid); and water ([0104]).
Regarding claim 2: The multivalent alcohol comprises 1,3-butylene glycol and xylitol.
Regarding claims 3 and 4: The betaine is trimethyl glycine which 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: Trimethyl glycine (i.e., component A) is present at 1% by weight while 1,3-butylene glycol is present at 4% by weight and xylitol at 1% by weight (i.e., component B). Such amounts result in a molar ratio of (A):(B) that falls within the instantly claimed range.
Regarding claim 6: The total amount of trimethyl glycine (i.e., component A), 1,3-butylene glycol, and xylitol (i.e., component B) is 6% by weight, which falls within the instantly claimed range.
Regarding claim 7: It is inherent that the trimethyl glycine (i.e., component A) with 1,3-butylene glycol and xylitol (i.e., component B) will form a complex when present in the same composition. 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.
Regarding claim 8: The logP of tranexamic acid (i.e., component C) is -2, as evidenced by the instant specification (p. 13, line 21 of spec.), which falls within the instantly claimed range.
Regarding claim 9: The skin condition improving ingredient is tranexamic acid, as discussed above.
Regarding claim 11: Given the claim interpretation above, claim 11 is anticipated by the same teachings as claim 1 above.
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 1-11 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, PTO-892), hereinafter Lubrano, in view of Yasuno, R., et al. (US 20060263399 A1, 11/23/2006, PTO-892), 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).
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.
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.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yasuno, R., et al. (US 20060263399 A1, 11/23/2006, PTO-892), hereinafter Yasuno.
The teachings of Yasuno are discussed above.
Yasuno further teaches that preparations were prepared by adding ascorbic acid to a mixed solution of trimethyl glycine, diethylene glycol monoethyl ether, 1,3-butylene glycol, polyoxyethylene (60) hardened castor oil, and water, and dissolving the mixture by heating and mixing the mixture ([0077]). Such a preparation method reads on first, forming a mixed solution which comprises the trimethyl glycine (i.e., component A) and 1,3-butylene glycol (i.e., component B), as instantly claimed, wherein such components would inherently form a complex as discussed above. Then, adding ascorbic acid (i.e. component C) to the mixed solution, as instantly claimed.
The teachings of Yasuno differ from those of the instant invention in that Yasuno does not explicitly teach adding the water last as defined in claim 10.
However, 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 add the water last in the preparation method of Yasuno since 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 added the water last in order 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 changing the point at which water is added would not change the composition of the final product.
Conclusion
No claims are allowed.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616