DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Applicant’s amendment of 08/10/2026 is acknowledged. Claims 1, 3-5,8, 10, 12-13, and 15-17 are amended. 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.
Declaration Under 37 CFR 1.132
Inventor Hasiba Bekto provided a Declaration under 37 CFR 1.132, filed 08/10/2026. The Declaration meets the formal requirements. In the most relevant part, the Declaration presents results evaluating ursolic acid as an antioxidant according to the present invention. A Declaration is due full consideration and weight for all that it discloses. Declarations are reviewed for the following considerations: 1) whether the Declaration presents a nexus such as a side-by-side or single-variable comparison (In re Huang, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996)), 2) whether the Declaration presents a comparison to the closest art, 3) whether the Declaration is commensurate in scope with the scope of the claims (In re Kulling, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)), 4) whether the Declaration shows a difference in kind rather than merely a difference in degree (In re Waymouth, 182 USPQ 290, 293 (C.C.P.A. 1974)), and 5) whether the prima facie case is sufficiently strong that allegedly superior results are insufficient to overcome the case for obviousness (Pfizer Inc. v. Apotex, Inc., 82 USPQ2d 1321, 1339 (Fed. Cir. 2007)).
The Declaration under 37 CFR 1.132 filed 08/10/2026 is insufficient to overcome the rejection of claims 1-20 as set forth in the last Office action for the following reasons: The relevant criteria here are No. 1-3 and 5. The Examiner has carefully reviewed the Declaration, including the data presented in the Declaration. The data demonstrate that a composition according to the instant invention (Example 6) comprising 0.20 wt.% ursolic acid, which is the antioxidant component taught by Lou, rather than an antioxidant selected from those recited in the amended claims results in a ΔE of 14.3, which Inventor Bekto notes as undesirable in terms of antioxidant effect on color stability.
Regarding criteria No. 1-3, while the data are presented as a single-variable comparison of the antioxidants used in the present invention to the ursolic acid employed in closest prior art (Lou et al.; WO2017194486A1; published: 11/16/2017; IDS of 11/16/2023), the data only reflect a composition comprising ursolic acid at a single concentration, 0.2 wt.%, whereas instant claim 1 does not limit the amount of antioxidant permitted in the composition and does not require that the composition has a particular color stability and/or ΔE value. Thus, the comparative data presented in the Declaration are not commensurate in scope with the instant claims.
Regarding criterion No. 5, even in view of the data presented in the Declaration, the instantly claimed antioxidant component, as amended, is still obvious in view of Lou in combination with the previously cited BASF reference (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892 of 03/09/2026). BASF explicitly teaches that pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate is routinely used as an antioxidant in cosmetic products because it protects oxygen sensitive ingredients from degradation during processing, handling and storage, thus maintaining the product’s performance and providing long-lasting shelf life (Page 4; previously cited). Because the stated goal of Lou is to impede oxidation of a retinoic acid precursor (Abstract; previously cited), an ordinarily skilled artisan would be highly motivated to include pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate in the prior art composition, regardless of the presence or absence of ursolic acid. Moreover, in view of the combined prior art teachings, wherein Lou teaches that slowed yellowing visually indicates improved stabilization (Pages 15-17, Examples 1-3; previously cited), Applicant’s observed color stability is reasonably expected in a composition comprising both resorcinol and pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate as stabilizing agents.
Thus, the Declaration does not overcome the prior art rejections of record at this time because the results demonstrated are not commensurate in scope with the claims and because Applicant’s allegedly superior antioxidant effect does not appear to be unexpected in view of the prior art teachings. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Previous Rejections/Objections
Applicant’s arguments filed 08/10/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied as necessitated by Applicant’s amendment to the claims. They constitute the complete set of rejections and/or objections presently being applied to the instant application. Applicant’s arguments insofar as they pertain to the present grounds of rejections and/or objections are addressed herein.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites the limitation “(f) an emulsifying polymer present in an amount of 0.01 to 5% by weight, wherein wherein”. The second recitation of the term “wherein” is a typographical error and should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 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.
Response to Arguments
Applicant’s arguments submitted on 08/10/2026 with respect to rejections under 35 U.S.C. 112(b) have been fully considered, but were not found to be persuasive. Applicant cites Fevola et al. (IDS of 08/10/2026) to submit that while the original usage of “Carbomer” was a tradename, it is now widely used in the art to refer to “a family of crosslinked acrylic acid polymers”. This argument was not found to be persuasive. The policy in MPEP 2173.05(u) is not limited to registered trademarks or those regarded by the Office as “live”. Even if the tradename’s meaning is well-known to the skilled artisan, that tradename may not appear in the claims because it does not define or describe the particular material or product associated with the name. Accordingly, the 112(b) rejection of record is maintained.
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 1-11 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) in view of BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892 of 03/09/2026).
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-hydroxystearic 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 (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 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 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.
However, Lou does not expressly teach that the composition further comprises an antioxidant selected from the list recited in claims 1 or 5, or the amount of antioxidant recited in claims 5, 6, or 13.
BASF teaches that pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate is a phenolic antioxidant for stabilization of oxidation sensitive cosmetic formulations (Page 4).
Regarding instant component (d) of claim 1: 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 claims 5, 6, and 13: 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 reads on the range recited in claim 5 and overlaps and thus renders obvious the ranges recited in claims 6 and 13, in order to achieve a desired antioxidant effect.
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 1-20 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) in view of BASF (“Technical Information: Tinogard® TT”, p. 1-4; published: 01/16/2019; PTO-892 of 03/09/2026), as applied to claims 1-11 and 13-20 above, and further in view of Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
The combination of Lou and BASF teaches the invention(s) of claims 1-11 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 combination of Lou and BASF 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 taught by the combination of Lou and BASF, 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 prior art as proposed because both Lou and Huang 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.
Response to Arguments
Applicant’s arguments submitted on 08/10/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered but were not found to be persuasive.
Applicant argues that in light of Inventor Bekto’s Declaration (discussed above), wherein a composition comprising ursolic acid results in an allegedly inferior ΔE value, a prima facie case of obviousness has not been established. This argument was not found to be persuasive in view of the previously cited BASF reference. First, the Examiner reiterates that instant claim 1 does not require a particular antioxidant concentration, color stability, and/or ΔE value. Thus, the comparative data presented in the Declaration are not commensurate in scope with the instant claims, which allow for any concentration of the recited antioxidants and are not limited to those having a particular stability. Further, because the stated goal of Lou is to impede oxidation of a retinoic acid precursor (Abstract; previously cited), and BASF explicitly teaches that pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate is routinely in cosmetic products to protect oxygen sensitive ingredients from degradation (Page 4; previously cited), an ordinarily skilled artisan would be highly motivated to include pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate in the prior art composition, regardless of the presence or absence of ursolic acid. The Examiner further notes that based on the prior art teachings, Applicant’s observed color stability is reasonably expected in a composition comprising both resorcinol and pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate as stabilizing agents.
Applicant further argues that the broad teachings of Lou effectively do not teach a compatible oil having a Hansen total solubility parameter of from 16.5 to 22, asserting that there is no clear motivation for one skilled in the art to pursue a particular cosmetically acceptable carrier over another as a starting point for routine optimization because the general conditions and parameters were not sufficiently disclosed in the cited reference. This argument was not found to be persuasive. Lou specifically names caprylic/capric triglyceride, which has a Hansen total solubility parameter within the claimed range, as a preferred carrier and employs this carrier in multiple exemplary embodiments (Page 8, line 32; Pages 15-16, Examples 1 & 2; previously cited). Contrary to Applicant’s assertion of hindsight selection from a “laundry list” of disclosed carriers, an ordinarily skilled artisan familiar with the teachings of Lou would very reasonably use its exemplary carrier as a starting point to improve upon the prior art composition. Regarding optimization of the amount of oil, the Examiner notes MPEP 2144.05(II)(A). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, Lou has indeed disclosed the general conditions of the instantly claimed range by teaching that 1 to 20 wt.% ester oil is most suitable for forming oil-in-water emulsions, which is the preferred form of the composition (Page 7, lines 10-30; Claim 8). It is well within the skillset of an ordinarily skilled artisan to determine wherein within a disclosed set of ranges is optimum for producing the most stable and effective composition. Absent a demonstration of the criticality of the instantly claimed range, the Examiner maintains that a proper prima facie case of obviousness has been established.
Applicant further argues that only polymers having either acrylates/C10-30 alkyl acrylate cross polymer or carbomer resulted in desirable ΔE values, while other well-known thickening agents failed to produce the desired stability, and that such discrepancy in type of thickening agent is not contemplated in Lou. Therefore, Applicant argues that one of ordinary skill in the art would not be motivated, taught, or suggested by Lou or Baumann to arrive at the pending claims. This argument was not found to be persuasive. First, the Examiner reiterates that instant claim 1 does not require a particular color stability and/or ΔE value. Even if it did, Applicant’s data are not commensurate in scope with the instant claims. In Applicant’s Example 3, thickeners according to the present invention (Samples 1 and 5-11) are implemented in a much narrower concentration range of 0.2 to 0.75 wt.%, whereas comparative Samples 11-19 are used in amounts of up to 3.5 wt%. It is unclear whether some of these comparative thickeners would have lower ΔE values at lower concentrations, and whether thickeners according to the present invention would have “undesirable” ΔE values when used at the higher end of the instantly claimed range (e.g., 1-5 wt.%). Therefore, Applicant’s argument of unexpected results is insufficient to overcome the prima facie case of obviousness established. Further, the reason or motivation to modify the reference may suggest what the inventor has done, but for a different purpose. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by Applicant. In the instant case, Lou clearly names carbomers as exemplary thickening agents and expressly teaches their use within the instantly claimed range. Therefore, the Examiner maintains that it would have been prima facie obvious to use any of the thickeners specifically disclosed by Lou, including carbomers, within the prior art range for its intended purpose of achieving a particular viscosity.
Applicant further argues that the other cited prior art has failed to reveal anything which would remedy the deficiencies of the art discussed above. The Examiner respectfully disagrees, particularly in view of the previously cited BASF reference, for the reasons discussed in detail above. Since all of the claimed elements were known in the prior art, one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A). In view of the foregoing, the prior art rejections of record 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 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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, and 12-hydroxystearic 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 ‘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 (d)-(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 component (d) of 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, Lou, and BASF 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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 and 12-hydroxystearic 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 ‘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, 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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, and Vitamin B3 (same as niacinamide), 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 ‘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, 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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, 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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, 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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 and 12-hydroxystearic 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, 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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, 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 of 03/09/2026), and Huang et al. (US20190358140A1; published: 11/28/2019; PTO-892 of 03/09/2026).
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, which is discussed in detail above.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments submitted on 08/10/2026 with respect to rejections on the ground of nonstatutory double patenting have been fully considered but were not found to be persuasive.
Applicant argues that the obviousness double patenting rejections should be withdrawn until the claims are in final form and otherwise in condition for allowance and until such time, there is no double patenting and no way to determine double patenting. Applicant further asserts that the obviousness-type double patenting rejection presented is not proper and should be withdrawn.
The Examiner respectfully disagrees and directs Applicant’s attention to MPEP 804. 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 the event that the application under examination has an earlier patent term filing date than the copending application, the provisional nonstatutory double patenting rejections must be maintained unless 1) it is overcome with claim amendments and/or arguments demonstrating that the claims are patentably distinct, 2) a proper terminal disclaimer is filed, or 3) it is the only remaining rejection and the instant application has the earlier patent term filing date relative to the reference application.
Since Applicant has not specifically pointed out how the instant claims are patentably distinct and non-obvious in view of the conflicting claims and supporting prior art references, the rejections are proper and will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejections.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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