DETAILED ACTON
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 07/17/2025 is acknowledged. Claims 10-16, 19, and 23-24 are amended; claim 18 is cancelled; and claims 28-30 are new. Claims 10-17 and 19-30 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/EP2021/064332 filed on 05/28/2021 and claims foreign priority to EP20177510.3 filed on 05/29/2020 as reflected in the filing receipt dated on 04/27/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Objections and Rejections
Applicant’s amendment to the specification has overcome the previous objection to the disclosure. Thus, the objection is hereby withdrawn.
Applicant’s amendment to the claims have overcome the previous objections to the claims. Thus, the objections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of rejection presented herein under 103. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of rejection presented herein under nonstatutory double patenting. Applicant’s arguments insofar as they pertain to the revised grounds of rejection are addressed herein.
Claim Objections
Claims 11, 14-17, 19-21, 23, and 25-28 are objected to because of the following informalities:
Claims 11, 14-17, 19-21, 23, and 25-28 improperly reference “Claim 1”, which is clearly a typographical error following the previous cancellation of claims 1-9. The claims should read, “The cosmetic composition according to Claim 10…”.
Appropriate correction is required.
The following grounds of rejection are new or modified as necessitated by Applicant’s amendment to the claims.
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 10-17, 19, and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Buchalova et al. 2019 (CA3069492A1; 01/17/2019; PTO-892 of 04/18/2025) in view of Oblong et al. 2003 (EP0896522B1; 10/22/2003; PTO-892 of 04/18/2025).
Buchalova discloses freeze dried active compositions (FDAC) that may be hydrated or added to end use compositions in order to yield compositions for delivering superior topical benefits to consumers (Abstract), including reducing facial lines, wrinkles, and color marks (Page 1, lines 14-17). The FDAC comprises: (a) active; (b) oil; (c) water; (d) emulsifier; and (e) thickening agent (Page 2, lines 15-30). All percentages disclosed by Buchalova are meant to be by weight unless stated otherwise (Page 3, lines 31-32). Preferably, the oil soluble active is a retinoic acid precursor including retinyl propionate among others (Page 4, lines 23-37 and Page 5, Lines 1-10), wherein the amount of oil soluble active is from 0.001 to 10% by weight of the total FDAC emulsion precursor (Page 6, lines 4-6). The FDAC emulsion precursors may optionally include water soluble actives like Vitamin B3 (also known as niacinamide), among others, such that the total amount of water-soluble actives present in the FDAC emulsion precursor may range from 0.01 to 4% by weight of the total FDAC emulsion precursor (Page 9, lines 15-31). Oils suitable for use include silicone oils and esters, among others, preferably from 5 to 75% by weight of the FDAC emulsion precursor.
In an exemplary embodiment (Page 14, Table III, Sample 8), an FDAC emulsion precursor comprises 1.0% retinyl propionate, 20.0% caprylic/capric triglyceride, and 67% water among other ingredients, by weight of the composition total composition.
Retinyl propionate reads on the retinoic acid precursor of instant claims 10-13, 25-26, and 29-30. The amount of retinyl propionate falls within the ranges recited in instant claims 11 and 12 and thus renders obvious the claims.
The caprylic/capric triglyceride reads on the oil having a Hansen total solubility parameter from 13 to 26 of instant claims 10 and 19, and having a Hansen solubility parameter of 15 to 25 of instant claim 17, as evidenced by the instant specification which states that caprylic/capric triglyceride is an example of a suitable oil for use (Instant Specification, Page 6, Lines 26-36). The amount of caprylic/capric triglyceride falls within the ranges recited in instant claims 10 and 29 and thus renders obvious the claims.
Regarding the amount of retinoic acid precursor recited in instant claims 13, 29, and 30, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of retinyl propionate within the range taught by Buchalova, which overlaps the instantly claimed ranges, because the reference teaches that any amount of oil soluble active between 0.001 to 10% by weight of the total FDAC emulsion precursor is suitable for forming a topical composition for reducing facial lines, wrinkles, and color marks. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding the emulsion comprising water recited in instant claims 28-30, the FDAC emulsion precursor is in the form of an emulsion prior to freeze-drying and comprises 66% water by weight of the total FDAC emulsion precursor, which lies within and thus renders obvious the claimed ranges.
Regarding the species of oil recited in instant claim 30, Buchalova explicitly teaches a limited list of suitable oils, including isopropyl myristate, isopropyl palmitate, caprylic/capric triglyceride, and mixtures thereof (Page 6, lines 18-27). Thus, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage a combination wherein isopropyl myristate, isopropyl palmitate, or a mixture of both is selected as the oil component in addition to or in place of caprylic/capric triglyceride. Note: MPEP 2131.02. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). Further, 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).
Regarding the amount of oil recited in instant claim 30, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of oil within the range taught by Buchalova, which overlaps the instantly claimed ranges, because the reference teaches that any amount of oil between 7 to 20% by weight of the total FDAC emulsion precursor (Page 6, lines 29-33) is suitable for forming a topical composition for reducing facial lines, wrinkles, and color marks. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding the limitation “leave-on composition” recited in instant claim 30, Buchalova teaches that upon rehydration of the FDAC, which would yield the same ingredients as the FDAC emulsion precursor prior to freeze-drying, the composition may be used as a cream or lotion, among other forms, for topical application to the skin (Page 3, lines 10-14). Without any direction to the contrary, one of skill in the art would apply a cream or lotion to the skin as a leave-on composition. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the emulsion as a leave-on cream or lotion as taught by Buchalova.
However, Buchalova does not expressly teach that the FDAC emulsion precursor comprises a functionalized heteroaromatic compound as recited in instant claims 10, 14-16, 27, and 29-30 in an amount recited in instant claims 14-16 and 29-30.
Oblong teaches that the combination of Vitamin B3 compound, especially niacinamide, and retinoid provide unexpected benefits in regulating skin condition, especially in cosmetically regulating signs of skin aging, more especially wrinkles, lines and pores (Paragraphs 0007 and 0116). The retinoid is preferably retinol, retinol esters including retinyl palmitate, retinyl acetate, and retinyl propionate, retinal, and/or retinoic acid (Paragraph 0117).
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 of Buchalova (Sample 8) by adding niacinamide, which reads on the functionalized heteroaromatic compound of instant claims 10, 14-16, 27, and 29-30. One of ordinary skill in the art would have been motivated to add niacinamide because Oblong teaches that the combination of Vitamin B3 and retinoids including retinyl propionate provide unexpected benefits in regulating skin condition, especially in regulating wrinkles and lines, which is aligned with the desired benefits of the compositions of Buchalova.
It is noted that the recitation “cosmetic” in instant claims 10 and 29-30 is an intended use of the claimed composition. 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 taught by the combination of Buchalova and Oblong is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Regarding the amount of niacinamide recited in instant claims 14-16 and 29-30, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of niacinamide in the composition taught by the combination of Buchalova and Oblong within the range taught by Buchalova, which lies within and thus renders obvious the instantly claimed ranges, because Buchalova teaches that any amount of water soluble active between 0.01 to 4% by weight of the total FDAC emulsion precursor is suitable for forming a topical composition for reducing facial lines, wrinkles, and color marks.
One of ordinary skill in the art would have a reasonable expectation of success because Buchalova teaches that its FDAC emulsion precursors may also comprise niacinamide.
Claims 10-17, 19-20, and 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Buchalova et al. 2019 (CA3069492A1; 01/17/2019; PTO-892 of 04/18/2025) in view of Oblong et al. 2003 (EP0896522B1; 10/22/2003; PTO-892 of 04/18/2025) as applied to claims 10-19 and 25-30 above, and further in view of Robinson et al. 2002 (CA2413276A1; 01/17/2002; PTO-892 of 04/18/2025).
The combination of Buchalova and Oblong teach the cosmetic composition according to instant claim 10 as discussed in detail above and further incorporated herein.
However, the combination of Buchalova and Oblong does not expressly teach that the composition further comprises at least one of a sunscreen, photostabilizer, skin-lightening agent, wrinkle-reducing agent, coloring agent, or a mixture thereof as recited in instant claim 20, or that the composition further comprises silicone in the amount recited in instant claims 23 and 24.
Robinson teaches compositions that regulate the condition of skin, including but not limited to reducing the appearance of fine lines and/or wrinkles on the skin and skin surface blemishes (Page 32, lines 22-27). In an exemplary embodiment (Page 34, Example 5), a water-in-silicone skin composition which comprises retinyl propionate, niacinamide, and isopropyl palmitate among other ingredients including silicones. Isopropyl palmitate is another suitable oil with a Hansen total solubility parameter from 13 to 26 as evidenced by instant claim 19. Silicone elastomers enhance the delivery of oil-soluble skin care actives, including vitamin B3 compounds and retinoids, into the skin (Page 5, lines 28-34 and Page 6, lines 1-2) and are preferably included in an amount from about 0.5 to 10% by weight of the composition (Page 11, lines 30-34). Robinson further teaches that exposure to ultraviolet light can result in excessive scaling and texture changes of the stratum corneum (Page 27, lines 5-8) and that 2-ethylhexyl-p-methoxycinnamate is a preferred sunscreen active in the composition (Page 28, lines 5-13).
Regarding instant claim 20, 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 taught by the combination of Buchalova and Oblong by adding a sunscreen active such as ethylhexylcinnamate as taught by Robinson. One of ordinary skill in the art would have been motivated to include a sunscreen to combat exposure to ultraviolet light, which results in unfavorable skin scaling and texture changes as taught by Robinson.
Regarding instant claims 23-24, 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 taught by the combination of Buchalova and Oblong by adding a silicone in an amount between about 0.5 to 10% by weight of the composition as taught by Robinson, which lies within the range recited in instant claim 23 and overlaps the range recited in instant claim 24. One of ordinary skill in the art would have been motivated to add a silicone in this amount to enhance the delivery of niacinamide (a vitamin B3 compound) and retinyl propionate (a retinoids) into the skin, as taught by Robinson. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
One of ordinary skill in the art would have a reasonable expectation of success because Robinson teaches that its compositions reduce fine lines, wrinkles, and blemishes on the skin, which aligns with the composition taught by the combination of Buchalova and Oblong, and Buchalova teaches that its FDAC emulsion precursors may also comprise niacinamide, a sunscreen like ethylhexylcinnamate, and silicone.
Claims 10-17, 19, 21-22, and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Buchalova et al. 2019 (CA3069492A1; 01/17/2019; PTO-892 of 04/18/2025) in view of Oblong et al. 2003 (EP0896522B1; 10/22/2003; PTO-892 of 04/18/2025) as applied to claims 10-19 and 25-30 above, and further in view of INCI Decoder 2019 (11/22/2019; PTO-892 of 04/18/2025).
The combination of Buchalova and Oblong teach the cosmetic composition according to instant claim 10 as discussed in detail above and further incorporated herein.
However, the combination of Buchalova and Oblong does not expressly teach that the composition further comprises a retinoid booster as recited in instant claim 21, wherein the retinoid booster comprises 12-hydroxystearic acid, cetyl alcohol, cetearyl alcohol, cocamide monoethanolamide, linoleoyl monoethanolamide, climbazole, or a mixture thereof as recited in instant claim 22.
INCI Decoder teaches Olay’s Professional ProX Deep Wrinkle Anti-Aging Treatment which is designed to treat deep, hard-to-combat wrinkles (Page 1). The treatment comprises niacinamide, retinyl propionate, caprylic/capric triglyceride, and cetyl alcohol among other ingredients (Page 2, “Ingredients overview”). INCI Decoder further teaches that cetyl alcohol, which reads on the retinoid booster recited in instant claims 21 and 22, is an emollient that makes skin feel smooth and nice, helps to thicken products, and is an emulsifier that helps water and oil to blend.
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 taught by the combination of Buchalova and Oblong by adding cetyl alcohol as taught by INCI Decoder. One of ordinary skill in the art would have been motivated to add cetyl alcohol for the added benefits of improving skin smoothness, adjusting the viscosity of the composition, and helping blend the water and oil components of the composition.
One of ordinary skill in the art would have a reasonable expectation of success because INCI Decoder teaches that cetyl alcohol can be used in combination with niacinamide, retinyl propionate, and caprylic/capric triglyceride to form compositions that combat wrinkles, as desired by the combination of Buchalova and Oblong.
Response to Arguments
Applicant’s arguments submitted on 07/17/2025 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 were not found to be persuasive.
Applicant argues that neither the FDAC nor the FDAC emulsion precursor taught by Buchalova is a ready-to-use composition. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., “ready-to-use”) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Since the combined teachings of Buchalova and Oblong teach all recited features of the composition, then it meets the claim.
Applicant further argues that determining a color stable and chemically stable composition comprising a retinoic acid precursor and a functionalized heteroaromatic compound is not as straightforward as combining the teachings of Buchalova with those of Oblong, noting that one of ordinary skill in the art would be deterred from combining the references due to stability issues relating to the claimed retinoic acid precursor and functionalized heteroaromatic compound. The Examiner reiterates that the features upon which Applicant relies (i.e., “stability”) are not recited in the rejected claims. The claims as presented do not require that the composition remains stable over a period of time. Furthermore, as cited in the prior art rejections above, Buchalova expressly permits the inclusion of “water soluble actives like…Vitamin B3 (niacinamide)” (Buchalova, page 9, lines 16-17) in the FDAC emulsion precursor, which preferably comprises a retinoic acid precursor as the oil soluble active, indicating that one of skill in the art would not be deterred from making such combination. The teachings of Oblong further bolster the motivation to include niacinamide by teaching the unexpected benefits afforded by combining a Vitamin B3 compound, especially niacinamide, with a retinoid (Oblong, paragraphs 0007 and 0116-0117). While Applicant also points to the criticality of a compatible oil to the claimed composition’s stability, the Examiner notes that the combination of Buchalova and Oblong teach a composition comprising 20.0 wt% caprylic/capric triglyceride, which lies within the instantly claimed concentration and, therefore, would be expected to achieve the same stabilizing effect. Therefore, the one of skill in the art would indeed be motivated to combine the prior art teachings as proposed and would have a reasonable expectation of success in doing so.
Regarding Applicant’s argument that the FDAC would only have about 3 to 5% by weight water, the Examiner notes that the FDAC emulsion precursor composition taught in the prior art rejections above comprises 66 wt.% water (Buchalova, page 14, Table III, Sample 8), which lies within and thus renders obvious the concentrations of water recited in new claims 28-30. Even when considering the FDAC itself, because Buchalova teaches rehydration of the FDAC prior to topical application, which would yield the same ingredients as the FDAC emulsion precursor composition, the prior art still reads on the claimed invention. Therefore, the prior art rejections above are maintained.
Regarding Applicant’s argument that the other cited prior art has failed to remedy the deficiencies of Buchalova and Oblong and that other claims in the application are patentable for Applicant’s reasons argued above, the argument was not found to be persuasive in view of the Examiner’s responses above. Therefore, the prior art rejections over the remaining dependent claims are maintained.
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.
Claims 10-17 and 19-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 12, 13, 15, and 16 of U.S. Patent No. 11,540,984 B2 in view of Buchalova et al. 2019 (CA3069492A1; 01/17/2019; PTO-892 of 04/18/2025) and Robinson et al. 2002 (CA2413276A1; 01/17/2002; PTO-892 of 04/18/2025).
US ‘984 claim 1 is drawn to a method of making an oil continuous nanoemulsion recited in claim 6. US ‘984 claim 8 recites that the nanoemulsion further comprises vitamin B3 and/or vitamin C in the water phase, and a resorcinol, retinyl propionate, retinyl palmitate, retinyl acetate, or a mixture thereof in the oil phase. Retinyl propionate, retinyl palmitate, and retinyl acetate read on the retinoic acid precursor of instant claims 10, 11-13, and 25. Retinyl propionate and retinyl palmitate read on the retinoic acid precursor of instant claims 29 and 30. US ‘984 claims 12 and 13 recite that the nanoemulsion further comprises 12-hydroxystearic acid, niacinamide, or a mixture thereof, which respectively read on the retinoid booster of instant claims 21 and 22 and the functionalized heteroaromatic compound of instant claims 10, 14-16, 27, and 29-30. US ‘894 claim 15 recites that the nanoemulsion further comprises a retinoic acid precursor, and claim 16 recites that it further comprises a retinyl propionate and a resorcinol, which reads on instant claims 26 and 29-30.
The claims of US ‘984 differ from the instant claims in that the claims of US ‘894 do not recite that the nanoemulsion comprises an oil with a Hansen total solubility parameter from 13 to 26 and makes up 15 to 25% by weight of the composition as recited in instant claim 10, the amount of retinoic acid precursor recited in instant claims 11-13 and 29-30, the amount of functionalized heteroaromatic compound recited in instant claims 14-16 and 29-30, the further limitations to the oil recited in instant claims 17, 19, and 29-30, that the composition further comprises at least one of a sunscreen, photostabilizer, skin-lightening agent, wrinkle-reducing agent, coloring agent, or a mixture thereof as recited in instant claim 20, the silicone recited in instant claims 23-24, or the emulsion comprising the amount of water recited in instant claims 28-30.
The teachings of Buchalova, Oblong, and Robinson are as set forth above.
Buchalova further teaches that skin actives like retinoids and resorcinols can be unstable (Page 1, lines 19-30), and that the oil is typically in an amount 4 to 25 times more by weight than the active used (Page 6, lines 29-33). Table IV illustrates the importance of the oil to active ratio, wherein a higher ratio unexpectedly yields more stable product having more active (Page 15, lines 1-6).
Regarding the instantly claimed oil, 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 recited in the claims of US ‘984 by using caprylic/capric triglyceride, isopropyl myristate, and/or isopropyl palmitate as the oil, which reads on the oil of instant claims 10, 17, 19, and 29-30, at an amount of 20% by weight of the composition, which lies within the range recited in instant claims 10 and 29-30, as the starting point for routine optimization, as taught by Buchalova, because Buchalova teaches the importance of a higher ratio of oil to active, in this case retinoic acid precursor, to increase the stability of the active.
Regarding the amounts of retinoic acid precursor and functionalized heteroaromatic compound, 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 taught by the combination of US ‘984 claims and Buchalova by adjusting the amounts of retinoic acid precursor and functionalized heteroaromatic compound within the ranges taught by Buchalova because the reference teaches that any amount of water-soluble active, including retinoic acid precursors, with the range from 0.001 to 10% by weight of the composition and any amount of oil-soluble active, including niacinamide, with the range from 0.01 to 4% by weight of the composition is suitable for forming a topical composition for reducing facial lines, wrinkles, and color marks. The amount of retinoic acid precursor lies within the range recited in instant claim 11 and overlaps the ranges recited in instant claims 12-13 and 29-30. The amount of niacinamide lies within the ranges recited in instant claims 14-16 and 29-30. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding instant claim 20, 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 taught by the combination of US ‘984 claims and Buchalova by adding a sunscreen active such as ethylhexylcinnamate as taught by Robinson. One of ordinary skill in the art would have been motivated to include a sunscreen to combat exposure to ultraviolet light, which results in unfavorable skin scaling and texture changes as taught by Robinson.
Regarding instant claims 23-24, 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 taught by the combination of US ‘984 claims, Buchalova, and Robinson by adding a silicone in an amount between about 0.5 to 10% by weight of the composition as taught by Robinson, which lies within the range recited in instant claim 23 and overlaps the range recited in instant claim 24. One of ordinary skill in the art would have been motivated to add a silicone in this amount to enhance the delivery of oil-soluble skin care actives, such as the functionalized heteroaromatic compound and retinoic acid precursor, into the skin, as taught by Robinson. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding the emulsion comprising water recited in instant claims 28-30, 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 taught by the combination of US ‘984 claims, Buchalova, and Robinson by using water in an amount between about 55 to 88% by weight of the composition, which overlaps and thus renders obvious the claimed ranges, because Buchalova teaches this amount is sufficient for forming a stable emulsion comprising an oil soluble retinoic acid precursor and a water soluble active, like niacinamide (Buchalova, page 6, lines 8-11).
Regarding the limitation “leave-on composition” recited in instant claim 30, Buchalova teaches that compositions comprised of the same ingredients may be formulated as creams or lotions, among other forms, for topical application to the skin (Page 3, lines 10-14). Without any direction to the contrary, one of skill in the art would apply a cream or lotion to the skin as a leave-on composition. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the emulsion as a leave-on cream or lotion as taught by Buchalova.
One of ordinary skill in the art would have a reasonable expectation of success because Robinson teaches compositions comprising retinoids, niacinamide, a sunscreen, and silicone to reduce fine lines, wrinkles, and blemishes on the skin.
Claims 10-17 and 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 11,452,693 B2 in view of Oblong et al. 2003 (EP0896522B1; 10/22/2003; PTO-892 of 04/18/2025), Buchalova et al. 2019 (CA3069492A1; 01/17/2019; PTO-892 of 04/18/2025), Robinson et al. 2002 (CA2413276A1; 01/17/2002; PTO-892 of 04/18/2025), and INCI Decoder 2019 (11/22/2019; PTO-892 of 04/18/2025).
US ‘693 claim 1 recites a freeze dried active composition comprising active composition comprising an active and an oil comprising capric caprylic triglyceride, among other ingredients, wherein the active is a retinoic acid precursor comprising retinyl propionate, retinyl palmitate, or a mixture thereof. The active reads on the retinoic acid precursor of instant claims 10-13, 25, and 26. The oil reads on the oil of instant claims 10, 17, and 19.
US ‘693 claim 14 recites that the oil makes up from 6 to 50% by weight of the composition, which overlaps the ranges recited in instant claim 10. It would have been obvious to one of ordinary skill in the art to adjust the amount of oil within the range recited in US ‘693 claims because the claims teach than any amount of oil between 6 to 50% by weight of the composition is suitable for producing a composition comprising oil and a retinoic acid precursor. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
The claims of US ‘693 differ from the instant claims in that the claims of US ‘693 do not recite that the composition comprises a functionalized heteroaromatic compound as recited in instant claims 10, 14-16, and 27, the amount of retinoic acid precursor recited in instant claims 11-13, that the composition further comprises at least one of a sunscreen, photostabilizer, skin-lightening agent, wrinkle-reducing agent, coloring agent, or a mixture thereof as recited in instant claim 20, that the composition further comprises a retinoid booster as recited in instant claims 21-22, that the composition further comprises the silicone recited in instant claims 23-24.
The teachings of Oblong, Buchalova, Robinson, and INCI Decoder are as set forth above.
Regarding the instantly claimed functionalized heteroaromatic compound, 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 recited in the claims of US ‘693 by adding niacinamide, which reads on the functionalized heteroaromatic compound of instant claims 10, 14-16, and 27. One of ordinary skill in the art would have been motivated to add niacinamide because Oblong teaches that the combination of a Vitamin B3 compound including niacinamide and retinoids including retinyl propionate provide unexpected benefits in regulating skin condition, especially in regulating wrinkles and lines.
It is noted that the recitation “cosmetic” in instant claim 10 is an intended use of the claimed composition. 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 taught by the combination of US ‘693 claims and Oblong is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Regarding the amounts of retinoic acid precursor and functionalized heteroaromatic compound, 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 taught by the combination of US ‘693 claims, Oblong, and Buchalova by adjusting the amounts of retinoic acid precursor and functionalized heteroaromatic compound within the ranges taught by Buchalova because the reference teaches that any amount of water-soluble active, including retinoic acid precursors, with the range from 0.001 to 10% by weight of the composition and any amount of oil-soluble active, including niacinamide, with the range from 0.01 to 4% by weight of the composition is suitable for forming a topical composition for reducing facial lines, wrinkles, and color marks. The amount of retinoic acid precursor lies within the range recited in instant claim 11 and overlaps the ranges recited in instant claims 12-13. The amount of niacinamide lies within the ranges recited in instant claims 14-16. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding instant claim 20, 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 taught by the combination of US ‘693 claims, Oblong, and Buchalova by adding a sunscreen active such as ethylhexylcinnamate as taught by Robinson. One of ordinary skill in the art would have been motivated to include a sunscreen to combat exposure to ultraviolet light, which results in unfavorable skin scaling and texture changes as taught by Robinson.
Regarding instant claims 21-22, 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 taught by the combination of US ‘693 claims, Oblong, Buchalova, and Robinson by adding cetyl alcohol as taught by INCI Decoder. One of ordinary skill in the art would have been motivated to add cetyl alcohol for the added benefits of improving skin smoothness, adjusting the viscosity of the composition, and helping blend the water and oil components of the composition.
Regarding instant claims 23-24, 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 taught by the combination of US ‘693 claims, Oblong, Buchalova, Robinson, and INCI Decoder by adding a silicone in an amount between about 0.5 to 10% by weight of the composition as taught by Robinson, which lies within the range recited in instant claim 23 and overlaps the range recited in instant claim 24. One of ordinary skill in the art would have been motivated to add a silicone in this amount to enhance the delivery of oil-soluble skin care actives, such as the functionalized heteroaromatic compound and retinoic acid precursor, into the skin, as taught by Robinson. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
One of ordinary skill in the art would have a reasonable expectation of success because Robinson teaches compositions comprising retinoids, niacinamide, a sunscreen, and silicone to reduce fine lines, wrinkles, and blemishes on the skin, and INCI Decoder teaches that cetyl alcohol can be used in combination with niacinamide, retinyl propionate, and caprylic/capric triglyceride for the same purpose.
Claims 10-17 and 19-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 8 of U.S. Patent No. 11,324,679 B2 in view of Oblong et al. 2003 (EP0896522B1; 10/22/2003; PTO-892 of 04/18/2025), Buchalova et al. 2019 (CA3069492A1; 01/17/2019; PTO-892 of 04/18/2025), Robinson et al. 2002 (CA2413276A1; 01/17/2002; PTO-892 of 04/18/2025), and INCI Decoder 2019 (11/22/2019; PTO-892 of 04/18/2025).
US ‘679 claim 1 recites a composition comprising a retinoic acid precursor selected from retinyl propionate, hydroxyanasatil retinoate, and mixtures thereof, and a cosmetically acceptable carrier, among other ingredients. The retinoic acid precursor reads on the same recited in instant claims 10-13 and 25-26. US ‘679 claim 2 recites that the retinoic acid precursor is present from 0.001 to 10% by weight of the composition, which lines within the range recited in instant claim 11 and overlaps the ranges recited in instant claims 12 and 13. US ‘679 claim 7 recites that the composition is an oil-in-water emulsion. US ‘679 claim 8 recites that the composition further comprises a component selected from sunscreen, niacinamide and 12-hydroxystearic acid, among others.
The claims of US ‘679 differ from the instant claims in that the claims of US ‘679 do not recite that the composition comprises a functionalized heteroaromatic compound as recited in instant claims 10, 14-16, 27-30, the oil recited in instant claims 10 and 17, 19, and 29-30, the amount of retinoic acid precursor recited in instant claims 11-13 and 29-30, that the composition further comprises at least one of a sunscreen, photostabilizer, skin-lightening agent, wrinkle-reducing agent, coloring agent, or a mixture thereof as recited in instant claim 20, that the composition further comprises a retinoid booster as recited in instant claims 21-22, or that the composition further comprises the silicone recited in instant claims 23-24, the amount of water recited in instant claims 28-30, or that the emulsion is a leave-on composition as recited in instant claim 30.
The teachings of Oblong, Buchalova, Robinson, and INCI Decoder are as set forth above.
Regarding the instantly claimed functionalized heteroaromatic compound, 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 recited in the claims of US ‘679 by adding niacinamide, which reads on the functionalized heteroaromatic compound of instant claims 10, 14-16, 27, and 29-30. One of ordinary skill in the art would have been motivated to add niacinamide because Oblong teaches that the combination of a Vitamin B3 compound including niacinamide and retinoids including retinyl propionate provide unexpected benefits in regulating skin condition, especially in regulating wrinkles and lines.
Regarding the instantly claimed oil, 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 taught by the combination of US ‘679 and Oblong by using caprylic/capric triglyceride, isopropyl myristate, and/or isopropyl palmitate as the oil, which reads on the oil of instant claims 10, 17, 19, and 29-30, at an amount of 20% by weight of the composition, which lies within the range recited in instant claims 10 and 29-30, as the starting point for routine optimization, as taught by Buchalova, because Buchalova teaches the importance of a higher ratio of oil to active, in this case retinoic acid precursor, to increase the stability of the active.
It is noted that the recitation “cosmetic” in instant claims 10 and 29-30 is an intended use of the claimed composition. 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 taught by the combination of US ‘679 claims, Oblong, and Buchalova is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Regarding the amounts of retinoic acid precursor and functionalized heteroaromatic compound, 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 taught by the combination of US ‘679 claims, Oblong, and Buchalova by adjusting the amounts of retinoic acid precursor and functionalized heteroaromatic compound within the ranges taught by Buchalova because the reference teaches that any amount of water-soluble active, including retinoic acid precursors, with the range from 0.001 to 10% by weight of the composition and any amount of oil-soluble active, including niacinamide, with the range from 0.01 to 4% by weight of the composition is suitable for forming a topical composition for reducing facial lines, wrinkles, and color marks. The amount of retinoic acid precursor lies within the range recited in instant claim 11 and overlaps the ranges recited in instant claims 12-13 and 29-30. The amount of niacinamide lies within the ranges recited in instant claims 14-16 and 29-30. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding instant claim 20, 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 taught by the combination of US ‘679 claims, Oblong, and Buchalova by adding a sunscreen active such as ethylhexylcinnamate as taught by Robinson. One of ordinary skill in the art would have been motivated to include a sunscreen to combat exposure to ultraviolet light, which results in unfavorable skin scaling and texture changes as taught by Robinson.
Regarding instant claims 21-22, 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 taught by the combination of US ‘679 claims, Oblong, Buchalova, and Robinson by adding cetyl alcohol as taught by INCI Decoder. One of ordinary skill in the art would have been motivated to add cetyl alcohol for the added benefits of improving skin smoothness, adjusting the viscosity of the composition, and helping blend the water and oil components of the composition.
Regarding instant claims 23-24, 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 taught by the combination of US ‘679 claims, Oblong, Buchalova, Robinson, and INCI Decoder by adding a silicone in an amount between about 0.5 to 10% by weight of the composition as taught by Robinson, which lies within the range recited in instant claim 23 and overlaps the range recited in instant claim 24. One of ordinary skill in the art would have been motivated to add a silicone in this amount to enhance the delivery of oil-soluble skin care actives, such as the functionalized heteroaromatic compound and retinoic acid precursor, into the skin, as taught by Robinson. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding the emulsion comprising water recited in instant claims 28-30, 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 taught by the combination of US ‘679 claims, Buchalova, Robinson, and INCI Decoder by using water in an amount between about 55 to 88% by weight of the composition, which overlaps and th