DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined
under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will
not be considered a new ground of rejection if the prior art relied upon, and the rationale
supporting the rejection, would be the same under either status.
Claim Status
Applicant’s preliminary amendment of 11/16/2023 is acknowledged. Claims 1 and 3-12 are amended, and claims 13-20 are new. Claims 1-20 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/EP2022/063453 filed on 05/18/2022 and claims foreign priority to EP21181573.3 filed on 06/24/2021 as reflected in the filing receipt dated on 04/22/2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11/16/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites required composition components along with “wherein” clauses further limiting said components. However, the format of the claim makes it difficult to ensure all claim limitations are clearly conveyed. For example, in component (e), the Hansen solubility limitation is embedded between the recitation “8 to 40%...by weight of the cosmetic composition”, which encompasses is a single limitation that should not be separated. Further, limitations to component (c) are embedded within limitations corresponding to component (e). For clarity, the Examiner recommends amending the claim to the following format:
“A cosmetic composition comprising:
an alkylresorcinol;
a retinoic acid precursor;
a functionalized heteroaromatic compound present in an amount of 0.001 to 5% by weight of the composition, wherein the functionalized heteroaromatic compound is a carboxylic acid functionalized heteroaromatic compound comprising nicotinic acid, picolinic acid, nicotinate, niacinamide, picolinamide, or a mixture thereof;
an antioxidant;
at least one compatible oil present in an amount of 8 to 40% by weight of the composition, wherein the oil has a Hansen total solubility parameter from 16.5 to 22;
an emulsifying polymer present in an amount of 0.01 to 5% by weight of the composition, wherein the emulsifying polymer comprises Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, or a mixture thereof.”
Claim 1 recites the limitations “Acrylates/C10-30 Alkyl Acrylate Crosspolymer” and “Carbomer”, which are inappropriately capitalized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “alkylresorcinol” and “antioxidant”. Because at least some alkylresorcinols are known in the prior art to possess antioxidant properties, as evidenced by Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023; see Abstract and Claims 10-12), it is unclear whether the composition must comprise an antioxidant that is separate from the claimed alkylresorcinol or whether an alkylresorcinol with known antioxidant properties is sufficient to meet both limitations. For the purposes of compact prosecution in the prior art rejections below and consistent with Applicant’s disclosed examples, the Examiner is interpreting the claim to mean that the antioxidant component must be a chemically different compound than the alkylresorcinol component.
Claims 2-20 are rejected by virtue of their dependency on claim 1, as they fail to resolve the ambiguity in question.
Claim 1 contains the trade name “Carbomer”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe poly(acrylic acid) polymers and, accordingly, the identification/description is indefinite.
Claims 2-20 are rejected by virtue of their dependency on claim 1, as they fail to resolve the ambiguity in question.
Claims 1, 3-5, 8, 13, and 15-17 each recite at least one instance of the limitation “% by weight”. It is unclear whether the term indicates total composition weight or component weight, etc. Therefore, the metes and bounds of the claim are indefinite. For the purpose of the prior art rejections below, the claim is interpreted to mean % by weight of the cosmetic composition, as recited in instant claim 6.
Claims 2-20 are rejected by virtue of their dependency on claim 1, as they fail to resolve the ambiguity in question.
Claim 4 recites the limitation “retinyl esters” followed by the singular limitation “retinal ester”. Because retinyl esters and retinal have distinct chemical structures, it is unclear what compound corresponds to “retinal ester”. Since an ordinarily skilled artisan could not readily ascertain the metes and bounds of the claimed invention, the claim is indefinite. Perhaps Applicant meant only to include “retinyl esters” and/or “retinal” as supported by the instant specification, which states that the compositions contain a retinoic acid precursor, which typically includes retinyl esters, retinol, retinal, or mixture thereof (Instant Specification, Page 5, last paragraph).
Claim 4 recites the limitation “wherein the retinoic acid precursor comprises…retinoic acid”. It is unclear how retinoic acid itself can also be considered a precursor to retinoic acid. Because the limitation improperly broadens the scope of the claim, the claim is indefinite.
Claim 10 recites the limitation “composition comprises less than 5% additional surfactants”. The limitation lacks sufficient antecedent basis because the claim depends from claim 1, which does not recite surfactant(s). The term “further” should be added to the claim, and the term “additional” should be removed from the claim, so as to properly further limit claim 1. The Examiner recommends amending the claim to read “composition further comprises less than 5% surfactants by weight of the composition”.
Claim 12 recites the limitation “a ΔE value of less than or equal to 6 at 4 weeks at 45°C”. It is unclear what is meant by the limitation “at 4 weeks”. At 4 weeks of what? At 4 weeks post-formulation of the composition? At 4 weeks post-use of the composition? Further, it is unclear whether the limitation “at 45°C” indicates the temperature at which ΔE is measured, the temperature held throughout the “4 weeks”, etc. Therefore, the scope of the claim is indefinite. For the purposes of compact prosecution in the prior art rejections below, the Examiner is interpreting the claim to mean that the ΔE value of the composition is less than or equal 6 after being subjected to 45°C conditions for 4 weeks, as is consistent with Applicant’s experimental data (Instant Specification, Pages 19-21).
Claim Interpretation
The Examiner is interpreting the term “compatible oil” to mean any oil possessing a Hansen total solubility parameter value within the range of 16.5 to 22, as is consistent with Applicant’s instant specification (Page 5, first paragraph).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023) as evidenced by Baumann (Dermatology News, p. 1-6; published: 03/14/2017; PTO-892).
Lou, throughout the reference, teaches a method for impeding oxidation of a retinoic acid precursor in a composition comprising the step of combining the retinoic acid precursor with a skin benefit agent comprising resorcinol and/or derivative thereof (Abstract and Claims).
Regarding claim 1: Lou, in Claim 1, recites a composition comprising: a retinoic acid precursor, which reads on instant component (a); a skin benefit agent comprising one or more of 4-methyl resorcinol, 4-ethyl resorcinol, 4-propyl resorcinol, 4-butyl resorcinol, 4-pentyl resorcinol, 4-hexyl resorcinol, 4-heptyl resorcinol, 4-octyl resorcinol, 4-isopropyl resorcinol, which are all alkylresorcinols and thus read on the instant component (b); and a cosmetically acceptable carrier.
Regarding instant component (c): Lou, in Claim 9, recites that the composition further comprises: creatine, 1,2-octanediol, sunscreen, conjugated linoleic acid, hydroxyl acid, niacinamide, 12-hydroxysearic acid, phenoxyethanol or a mixture thereof. Therefore, an ordinarily skilled artisan could readily envision an embodiment wherein the composition comprises niacinamide, which reads on instant component (c). Regarding the claimed amount of instant component (c): Lou teaches that niacinamide is optimally present from 0.01 to 0.5% by weight of the composition, which reads on the instantly claimed range.
Regarding instant component (d): Lou, in Claim 6, recites that the composition further comprises: a retinoid booster, being climbazole, bibonazole, farnesole, glycyrrchetinic acid, ursolic acid, geranyl geraniol, oleyl betaine, hexanoyl sphingosine, or mixtures thereof. Therefore, an ordinarily skilled artisan could readily envision an embodiment wherein the composition comprises ursolic acid, which inherently has significant antioxidant properties as evidenced by Baumann (Page 1, first paragraph) and thus reads on instant component (d).
Regarding instant component (e): Lou exemplifies caprylic/capric triglyceride as the preferred carrier (Page 8, line 32; Pages 15-16, Examples 1 and 2), which reads on instant component (e) as evidenced by instant claim 9. Regarding the claimed amount of instant component (e): It would have been obvious to one of ordinary skill in the art to manipulate the amount of carrier using 20% by weight of the composition, which lies within and thus renders obvious the instantly claimed range, as a starting point for routine optimization because Lou explicitly teaches this amount is most suitable for forming oil-in-water emulsions, which is the preferred form of the composition (Page 7, lines 10-30; Claim 8).
Regarding instant component (f): Lou teaches that the composition may comprise 0.1 to 2% of a thickener, and explicitly names carbomers as effective thickening agents (Page 10, lines 13-32). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further include a carbomer as a thickening agent in an amount of 0.1 to 2% by weight of the composition, which reads on the instantly claimed range, to achieve a desired viscosity.
Regarding claim 2: All alkylresorcinols recited in the claims of Lou have an alkyl substituent at the 4-position and thus meet the claim limitation.
Regarding claim 3: Lou exemplifies compositions comprising 4-ethyl resorcinol or 4-hexyl resorcinol (Pages 15-16, Examples 1 and 2), which read on the same as instantly claimed. Regarding the claimed amount of alkylresorcinol: Each example uses the alkylresorcinol at 0.35 wt.% of the composition, which reads on the instantly claimed range.
Regarding claim 4: Lou exemplifies compositions comprising retinyl propionate or retinol (Pages 15-16, Examples 1 and 2), which read on the same as instantly claimed. Regarding the claimed amount of retinoic acid precursor: Each example uses the retinoic acid precursor at 0.1 to 0.4 wt.% of the composition, which reads on the instantly claimed range.
Regarding claim 6: Lou teaches that additives such as ursolic acid collectively makeup about 0.001 to 12% by weight of the composition. As an additive, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add an amount customary in the art to achieve its particular function. Since ursolic acid is a known antioxidant, as evidenced by Baumann, one skilled in the art would have been motivated to manipulate the amount of the compound within the range taught by Lou, which overlaps and thus renders obvious the instantly claimed amount, in order to achieve a desired antioxidant effect.
Regarding claim 7: Caprylic/capric triglyceride has a Hansen total solubility parameter of 18.9, as evidenced by Applicant’s instant specification (Page 6, last paragraph), which reads on the instantly claimed range.
Regarding claim 8: For the reasons discussed in relation to instant claim 1, the amount of caprylic/capric triglyceride taught by Lou lies within and thus renders obvious the instantly claimed range.
Regarding claim 9: Caprylic/capric triglyceride reads on the same as instantly claimed.
Regarding claim 10: The composition of Lou does not comprise additional surfactants. Thus, the amount reads on the instantly claimed range, which includes zero.
Regarding claim 11: As discussed above, Lou recites that the composition further comprises: creatine, 1,2-octanediol, sunscreen, conjugated linoleic acid, hydroxyl acid, niacinamide, 12-hydroxysearic acid, phenoxyethanol or a mixture thereof. Therefore, an ordinarily skilled artisan could readily envision an embodiment wherein the composition comprises a sunscreen and/or 12-hydroxystearic acid, which read on the same as instantly claimed.
Regarding claim 13: For the reasons discussed in relation to instant claim 6, the amount of ursolic acid taught by Lou overlaps and thus renders obvious the instantly claimed range.
Regarding claim 14: For the reasons discussed in relation to instant claim 7, the Hansen total solubility parameter of caprylic/capric triglyceride reads on the instantly claimed range.
Regarding claims 15-16: For the reasons discussed in relation to instant claim 1, the amount of caprylic/capric triglyceride taught by Lou lies within and thus renders obvious the instantly claimed range.
Regarding claim 17: For the reasons discussed in relation to instant claim 1, the amount of carbomer taught by Lou reads on the instantly claimed range.
Regarding claim 18: 4-ethyl resorcinol and 4-hexyl resorcinol read on the same as instantly claimed.
Regarding claim 19: Retinyl propionate and retinol read on the same as instantly claimed.
Regarding claim 20: For the reasons discussed in relation to instant claim 1, an ordinarily skilled artisan could readily envision an embodiment wherein the composition comprises niacinamide.
Claims 1-11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), as applied to claims 1-4, 6-11, and 13-20 above, and further in view of BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892) and as evidenced by Baumann (Dermatology News, p. 1-6; published: 03/14/2017; PTO-892).
Lou as evidenced by Baumann teaches the invention(s) of claims 1-4, 6-11, and 13-20 as discussed in detail above and further incorporated herein.
However, Lou does not expressly teach that the composition comprises an antioxidant selected from the list recited in claim 5.
BASF teaches that pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate is a phenolic antioxidant for stabilization of oxidation sensitive cosmetic formulations (Page 4).
Regarding claim 5: 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 Lou by further including pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate as an antioxidant because BASF teaches that it protects oxygen sensitive ingredients, like the retinoic acid precursor of Lou, from degradation during processing, handling and storage, thus maintaining the product’s performance and providing long-lasting shelf life (Page 4).
Regarding the claimed amount of antioxidant: Lou teaches that any oil soluble skin benefit agents or additives may be used to make up the portion of the skin benefit agent that is not resorcinol-based (Page 14, lines 11-16). BASF explicitly teaches that pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate is soluble in caprylic/capric triglyceride (Page 4). Because the composition of Lou comprises 0.35 wt.% alkylresorcinol and most preferably comprises 0.1 to 3.5 wt.% of skin benefit agent, it would have been obvious to one of ordinary skill in the art to use pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate within the range of 0.1 to 3.15 wt.%, which lies within and thus renders obvious the claimed range.
An ordinarily skilled artisan would reasonably expect success in modifying the composition of Lou with the teachings of BASF as proposed because both references desire stability of compositions comprising oxygen sensitive ingredients like retinoic acid precursors to prevent product degradation and provide a lasting shelf-life, and Lou expressly teaches that the skin benefit agent comprising resorcinol and/or derivative is limited only to the extent that it is suitable for formulating in compositions, especially topical compositions (Lou; Page 5, lines 20-24).
Claims 1-4 and 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), as applied to claims 1-4, 6-11, and 13-20 above, and further in view of Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892) and as evidenced by Baumann (Dermatology News, p. 1-6; published: 03/14/2017; PTO-892).
Lou as evidenced by Baumann teaches the invention(s) of claims 1-4, 6-11, and 13-20 as discussed in detail above and further incorporated herein.
Lou further teaches that the compositions are stored at 45°C and evaluated at 0 weeks and 4 weeks to assess retinoic acid precursor stability over time, wherein slowed yellowing of the composition visually indicates improved stabilization (Pages 15-17, Examples 1-3). For example, at 0.35 wt.% 4-hexyl resorcinol and 0.37 wt.% retinyl propionate, which each lie within the instantly claimed ranges, the alkylresorcinol completely prevents breakdown and oxidation of the retinoic acid precursor (Example 2).
While the reference is silent as to the ΔE value of the composition at 4 weeks at 45°C, which may in fact be less than or equal to 6 as recited in instant claim 12, the teachings of Huang render obvious the claimed value.
Huang, also drawn to compositions comprising skin benefit agents like antioxidants and 4-alkyl substituted resorcinol, teaches methods for assessing the color stability (ΔE) of a composition based on color measurements collected just after the composition is made and at the end of 4 weeks of storage at 45°C (Abstract; Paragraphs 0088-0090 and 0105). Huang teaches that a lower ΔE value indicates increased color stability, wherein its most stable composition achieved a ΔE value of 5.15 by including a compatible chelator (Paragraph 0089 and 0105).
Regarding claim 12: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the formulation of Lou, for example by including a chelating agent as taught by Huang, in order to achieve a ΔE of 5.15 or less at 4 weeks at 45°C, which lies within and thus renders obvious the instantly claimed range. An ordinarily skilled artisan would have been motivated to achieve a low ΔE because Huang teaches that a lower value indicates the skin benefit agent has not degraded in terms of chemical activity and/or color stability (Abstract; Paragraphs 0070-0092).
An ordinarily skilled artisan would reasonably expect success in modifying the composition of Lou based on the teachings of Huang because both references desire stability of compositions comprising the same skin benefit agents for at least 4 weeks at 45°C and recognize that a change in composition color is an indicator of undesirable product degradation.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892) as evidenced by Baumann (Dermatology News, p. 1-6; published: 03/14/2017; PTO-892).
The claims of US ‘679 recite a composition comprising: (a) a retinoic acid precursor selected from retinyl propionate and one other; (b) a skin benefit agent selected from 4-ethyl resorcinol, 4-hexyl resorcinol, and two other 4-alkylresorcinols; and (c) a cosmetically acceptable carrier. The retinoic acid precursor and skin benefit agent are each present from 0.001% to 10% by weight of the composition, which render obvious the instantly claimed ranges. The composition further comprises a component selected from sunscreen, niacinamide, 12-hydroxystearic acid, and ursolic acid, among a limited list of other components, and thus would be obvious to include them. As discussed above, ursolic acid is a known antioxidant as evidenced by Baumann. The claims do not recite that the composition comprises additional surfactants.
The claims of US ‘679 differ from in the instant claims in that the claims of US ‘679 do not expressly recite that niacinamide is present in the instantly claimed amount, or that the composition comprises components (e)-(f) of instant claim 1. Further, the claims of US ‘679 do not expressly recite the limitations of instant claims 5-9 or 12-17.
The teachings of Lou, BASF, and Huang as evidenced by Baumann are as set forth above and further incorporated herein.
Regarding the amount of niacinamide recited in instant claim 1: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘679 by using niacinamide within the range of 0.01 to 0.5% by weight of the composition, which reads on the instantly claimed range, because Lou teaches that this is the optimal concentration of vitamins like niacinamide when used in skin benefit compositions comprising a retinoic acid precursor and a resorcinol.
Regarding component (e) of instant claims 1, 7-9, and 14-16: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘679 by using caprylic/capric triglyceride as the carrier because Lou exemplifies caprylic/capric triglyceride as the preferred carrier for skin benefit compositions comprising a retinoic acid precursor and a resorcinol. Regarding the claimed amount of instant component (e): It would have been obvious to one of ordinary skill in the art to manipulate the amount of carrier using 20% by weight of the composition, which lies within and thus renders obvious the instantly claimed range, as a starting point for routine optimization because Lou explicitly teaches this amount is most suitable for forming oil-in-water emulsions, which is the preferred form of the recited composition (US ‘679, Claim 7).
Regarding component (f) of instant claims 1 and 17: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘679 by further including a carbomer as a thickening agent in an amount of 0.1 to 2% by weight of the composition, which reads on the instantly claimed range, to achieve a desired viscosity because Lou teaches that carbomers in this amount are particularly useful in skin benefit compositions comprising a retinoic acid precursor and a resorcinol.
Regarding instant claims 5-6 and 13: It would have been obvious to one of ordinary skill in the art to modify the composition taught by the combination of US ‘679 claims and Lou by further including pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate as an antioxidant because BASF teaches that it protects oxygen sensitive ingredients, like retinoic acid precursors, from degradation during processing, handling and storage, thus maintaining the product’s performance and providing long-lasting shelf life. Regarding the claimed amount of antioxidant: Because Lou teaches than non-resorcinol based skin benefit agents are useful in combination with resorcinol-based skin benefit agents when used collectively in an amount of 0.1 to 3.5 wt.% of the composition, it would have been obvious to one of ordinary skill in the art to use pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate within the prior art range, which lies within the ranges recited in instant claim 5 and overlaps the range recited in instant claims 6 and 13 and, thus, renders obvious the claimed ranges.
Regarding instant claim 12: It would have been obvious to one of ordinary skill in the art to optimize the formulation taught by the combination of US ‘679 claims and Lou, for example by including a chelating agent as taught by Huang, in order to achieve a ΔE of 5.15 or less at 4 weeks at 45°C, which lies within and thus renders obvious the instantly claimed range. An ordinarily skilled artisan would have been motivated to achieve a low ΔE because Huang teaches that a lower value indicates the skin benefit agent has not degraded in terms of chemical activity and/or color stability.
An ordinarily skilled artisan would reasonably expect success in modifying the claims of US ‘679 with the prior art as proposed because all components and concentrations are known in the art to be useful in formulating shelf-stable skin benefit compositions comprising a retinoic acid precursor and a resorcinol.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-9 of U.S. Patent No. 11,826,449 B2 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892) as evidenced by Baumann (Dermatology News, p. 1-6; published: 03/14/2017; PTO-892).
The claims of US ‘449 recite a composition comprising: (a) a retinoic acid precursor selected from retinyl propionate and one other; (b) a skin benefit agent selected from 4-ethyl resorcinol, 4-hexyl resorcinol, and two other 4-alkylresorcinols; (c) niacinamide; and (d) a cosmetically acceptable carrier. The retinoic acid precursor and skin benefit agent are each present from 0.001% to 10% by weight of the composition, which render obvious the instantly claimed ranges. The composition further comprises a component selected from sunscreen, 12-hydroxystearic acid, and ursolic acid, among a limited list of other components, and thus would be obvious to include them. As discussed above, ursolic acid is a known antioxidant as evidenced by Baumann. The claims do not recite that the composition comprises additional surfactants.
The claims of US ‘449 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-12 of U.S. Patent No. 12,233,144 B2 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892) as evidenced by Baumann (Dermatology News, p. 1-6; published: 03/14/2017; PTO-892).
The claims of US ‘144 recite a composition comprising: (a) a retinoic acid precursor selected from retinyl propionate and one other; (b) a skin benefit agent selected from 4-ethyl resorcinol, 4-hexyl resorcinol, and two other 4-alkylresorcinols; and (c) at least one humectant. The retinoic acid precursor and skin benefit agent are each present from 0.001% to 10% by weight of the composition, which render obvious the instantly claimed ranges. The composition further comprises a component selected from sunscreen, 12-hydroxystearic acid, ursolic acid, and Vitamin B3 (same as niacinamide), among a limited list of other components, and thus would be obvious to include them. As discussed above, ursolic acid is a known antioxidant as evidenced by Baumann. The claims do not recite that the composition comprises additional surfactants.
The claims of US ‘144 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,596,586 B2 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892).
The claims of US ‘586 recite a composition comprising: (a) glutathione precursor comprising 0.001 to 3% of a resorcinol selected from 4-hexylresorcinol, 4-ethyl resorcinol, and one other; (b) 0.005% to 2% of a retinoid selected from retinyl esters, including retinyl propionate and two others; and (c) a cosmetically acceptable carrier. The composition further comprises 0.0001% to about 10% of at least one vitamin selected from Vitamin B3 (same as niacinamide), among a limited list of other components, and thus it would be obvious to include. The claims do not recite that the composition comprises additional surfactants.
The claims of US ‘586 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
Regarding instant claim 11: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of US ‘586 by further including a sunscreen to achieve a desired level of sun protection and would have a reasonable expectation of success because Lou teaches that sunscreen actives are useful in skin benefit compositions comprising a retinoic acid precursor and a resorcinol.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,759,412 B2 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892).
The claims of US ‘412 recite a composition comprising: (a) glutathione precursor comprising 0.001 to 3% of a resorcinol selected from 4-hexylresorcinol, 4-ethyl resorcinol, and one other; (b) hydroxystearic acid; and (c) a cosmetically acceptable carrier. The composition further comprises 0.0001% to about 10% of at least one vitamin selected from Vitamin A and Vitamin B3 (same as niacinamide), among a limited list of other components, and thus it would be obvious to include them. The claims recite that the Vitamin A is a retinoid selected from retinyl esters, including retinyl propionate and two others. The claims do not recite that the composition comprises additional surfactants.
The claims of US ‘412 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,478,566 B2 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892) as evidenced by Baumann (Dermatology News, p. 1-6; published: 03/14/2017; PTO-892).
The claims of US ‘566 recite a composition comprising: 4-ethyl resorcinol, 4-hexyl resorcinol or both, and retinyl propionate, retinol, or both, as well as an oil and an emulsifier. In claim 15, the composition comprises niacinamide, retinyl propionate and 4-hexyl resorcinol. The composition further comprises a component selected from sunscreen, 12-hydroxystearic acid, and ursolic acid, among a limited list of other components, and thus would be obvious to include them. The claims do not recite that the composition comprises additional surfactants.
The claims of US ‘566 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/846,467 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of App. ‘467 only differ from the instant claims in that they do not expressly recite that the composition comprises an antioxidant as recited in instant claims 1, 5-6, and 13, or the further limitations of instant claims 8, 11-12, and 15-16.
The claims of App. ‘467 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
Regarding instant claim 11: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘467 by further including a sunscreen to achieve a desired level of sun protection and would have a reasonable expectation of success because Lou teaches that sunscreen actives are useful in skin benefit compositions comprising a retinoic acid precursor and a resorcinol.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/642,732 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of App. ‘732 only differ from the instant claims in that they do not expressly recite that the composition comprises an emulsifying polymer as recited in instant claims 1 and 17, or the further limitation of instant claim 12.
The claims of App. ‘732 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-17 and 19-30 of copending Application No. 17/925,371 in view of Lou et al. (WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of App. ‘371 only differ from the instant claims in that they do not expressly recite that the composition comprises component (a) as recited in instant claims 1-3 and 18, component (d) as recited in instant claims 1, 5-6, and 13, and component (f) as recited in instant claims 1 and 17, or the further limitation of instant claim 12.
The claims of App. ‘371 are rejected for the same/similar reasons as discussed above in the double patenting rejection over claims 1-5 and 7-17 of U.S. Patent No. 11,324,679 B2 in view of Lou, BASF, and Huang and as evidenced by Baumann, which is discussed in detail above.
Regarding component (a) of instant claims 1-3 and 18: It would have been obvious to one of ordinary skill in the art to modify the composition recited in the claims of App. ‘371 by further including 4-hexylresorcinol or 4-ethylresorcinol because Lou teaches that these prevent oxidation of retinoic acid precursors. Regarding the claimed amount of alkylresorcinol: Because Lou teaches that 4-alkylresorcinols are useful in an amount of 0.1 to 3.5 wt.% of the composition, it would have been obvious to one of ordinary skill in the art to use the compound within the prior art range.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616