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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 12/26/2025 has been entered.
Status of the Claims
Claims 1-9, 12, 13, and 17-24 are pending and under current examination. No claim amendments were filed concurrent with the RCE dated 12/26/2025.
The claims under examination are dated 11/20/23 in the file wrapper and are the most recent claims of record. All claims corresponding to the RCE filed 12/26/2025 have been addressed in the record, and it is noted that the decision of the Patent Trial and Appeal Board dated 10/31/2025 in the file wrapper affirmed the rejections appealed.
Response to Arguments
Applicant’s arguments filed 12/26/2025 (hereafter, “Remarks”) have been fully considered and are addressed as follows. Applicant’s summary of the rejection of record, the references previously cited, and the claims under examination as outlined on page 2 of Remarks are noted. Applicant cites case law particularly on pages 8 and 9 and re-iterates standards for establishing obviousness.
As to Applicant’s argument that neither Nielsen nor Garces teaches the claimed range of glycerin and that Simon does not cure this deficiency, this argument is not persuasive since Simon is relied upon for teaching glycerin or glycerol in a relatively increased amount over Garces and Nielsen in a similar formulation, a cosmetic emulsion. Simon is not limited to a reading of its examples, and its relevance is maintained as in the record. On page 9, Applicant argues that neither Weisman nor the cited references teach criticality of higher amounts of glycerol or glycol; Applicant then concludes that there is no reason to modify the compositions of the prior art to derive the claimed inventions and that the rejection should be withdrawn. In reply, please see Simon’s teaching which is relevant here for the reasons of record. It is maintained that Nielsen and Garces teach the use of glycols in their compositions and include an example with up to 10% weight glycol, and neither Nielsen nor Garces provide a teaching limiting the amount of glycerol. Moreover, Simon teaches a polyol range from 0.5 to 60% by weight as well as narrower ranges and specific values included within the instantly claimed range (see Simon column 4, lines 29-34). All together, these three references teach the use of glycerol and relate to cosmetic emulsions, and it is maintained that one reasonably would have looked to Simon as to how much glycerol to use. Moreover, Nielsen does not say that the level of polyol was the reason why Simon’s approach did not work, and absent such a statement, Nielsen is not interpreted to discourage use of polyols in amounts taught by Simon, particularly since Nielsen teaches the use of glycerol.
Applicant argues that the cited references disclose an “encyclopedic listing of possible active agents along with the broad range of amounts mentioned by Simon” and concludes that one would not have been motivated to Simon to select an amount of retinol in the range claimed. In reply, Nielsen and Garces are relied upon for teaching retinol.
As to Weisman, Applicant argues that according to Wikipedia’s entry for “sodium polyacrylate”, sodium polyacrylates differ materially from acrylic acid polymers in Nielsen and that these are not equivalents or interchangeable; Applicant concludes that the rejection should be withdrawn because Weisman renders the references inoperable for their intended purpose. In reply, it is maintained that Weisman is relevant in combination with Nielsen since Nielsen teaches polyacrylates or polyacrylic acids (but not a sodium salt) and that Weisman provides specific teaching of sodium polyacrylate in a specific amount in a formulation which may be in the form of an emulsion and which may comprise retinol.
Applicant asserts that Weisman illustrates the inventiveness of the instant application and cites case law in alleged support of his position; Applicant characterizes Neilson, Garces, and Simon as seeking to improve the stability of lipophilic active ingredients in o/w emulsions in alleged contrast with Weisman which uses an anhydrous concentrate separate from a hydration component which are not mixed until consumer use. Further regarding the Weisman reference, Applicant argues difficulty to predict the results and that one would not have expected success with stability, retinol activity preservation, skin penetration, etc. (see pages 7 and 8 of Remarks). In reply, Applicant’s argument has been considered but is not persuasive in view of Weisman considered as a whole which encompasses end result emulsion products which contain oil soluble components in a water-based composition (see [0011] and Weisman claim 1 in particular). Weisman has been cited for its teachings of a particular polyacrylate salt which is the sodium polyacrylate in retinol-containing formulations, which are noted to be liquid dispersions, where Nielsen teaches generally polyacrylates or polyacrylates and does not name the sodium polyacrylate salt in particular. As to Applicant’s position that Weisman illustrates inventiveness of the instant application by teaching formulations which are emulsions can be difficult to formulate, this argument has been considered but is not persuasive in view of what Weisman teaches as a whole, which is that the ordinary artisan would need to consider stability and aesthetic characteristics upon formulation of polymer preparations and/or emulsion.
Applicant asserts that none of the cited art is concerned with the problem of delivering high amounts of retinol deep into the skin without high amounts of oil, and on page 10 of Remarks emphasizes his position that the problem confronted by the inventor must be considered in determining obviousness; Applicant cites various case law on page 10 of Remarks and concludes that “the problem solved according to the Board’s Decision and Opinion is illusory or non-existent. One would not seek to modify cosmetic compositions of Neilson to achieve what the compositions therein have already achieved.”
In reply, the reason or motivation to modify the reference may suggest what the inventor has done, but for a different purpose or to solve a different problem where it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant; nevertheless, the prior art pertains to topical formulations comprising overlapping components, benefit and functional agents, which would have been obvious to use in combination further for the reasons of record, which have been affirmed by the Board. It is noted that no claim amendments have been presented concurrent with the filing of the RCE dated 12/26/2025 after the Board’s decision dated 10/31/2025, and no new rationale have been applied herein.
Applicant cites MPEP 2143 Example 3 and notes that an extra process step adding work and expense for no apparent reason is not the same as combining known art elements. In reply, this citation is not applicable as an argument here since under examination are composition (product) claims comprising elements addressed in the record, and no process step has been claimed or examined. It is not established by evidence in the record that an extra process step would be necessary to combine the prior art elements as in the rejection of record.
Applicant asserts on page 11 of Remarks that the rejection is predicated on improper hindsight; Applicant’s citation of case law pertaining to hindsight reconstruction is noted. In reply, any judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of the ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from Applicant’s disclosure, such a reconstruction is proper and, here, it is the examiner’s position that the combination of cited references reasonably provide the state of the art with regard to cosmetic emulsions containing a lipophilic component which may be a retinol component further for the reasons of record.
On page 12 of Remarks, Applicant argues that “…Per se rules that eliminate the need for fact-specific analysis of claims and prior art may be administratively convenient for PTO Examiners and the Board….legally incorrect and must cease…inconsistent with section 103…” and cites additional various case law as to what constitutes a case of obviousness, reasonable expectation of success, predictable result, motivation to combine, predictable solution in the art, etc. In reply, Applicant’s arguments have been considered, however it is the examiner’s position that MPEP guidance has been properly followed and that the record clearly shows a prima facie case of obviousness complete with articulated rationale.
Maintained Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 12, 13 and 17-24 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2003030859A1 (hereafter, “Nielsen” et al.) in view of US 2003/0064106A1 (hereafter, “Garces” et al.), Simon (US 5932234), and Weisman (US 2017/0156997 A1).
The instant claims are drawn to a composition comprising the following components: (a) retinol; (b) sodium polyacrylate; (c) one or more nonionic emulsifier; (d) a fatty phase; (e) water; and (f) one or more polyols selected from glycerin, glycols, or a mixture thereof, as further specified in the claims.
Nielsen teaches o/w emulsions for use in cosmetic formulations wherein the emulsions comprise cosmetic active agents including retinoids for instance as well as lipophilic and water components (see Nielsen abstract and claims 1-3 in particular). Retinol is included as an active agent desirably included in an encapsulated form (see page 2/24 of translation, last paragraph in particular) and in a concentration between 0.001 and 2% by weight of the total formulation (see Nielsen claim 6)(limitation of claim 1a).
Nielsen’s formulations may comprise a nonionic emulsifier such as glyceryl monostearates (see page 8/24 of translation, three paragraphs from the bottom of the page)(limitation of claims 1c and claim 3). Nielsen’s fatty or oil phase in the emulsions may be selected from those named including C2-C15 alkyl benzoate (paragraph 4 of page 8/24 of translation)(limitation of claim 1d, 5, 6, and 7) and caprylic acid triglyceride (page 7/24 and paragraph 3 of page 8/24 of translation)(limitation of claims 1d, 5, and 8). Nielsen teaches that the formulations may be gels comprising water and thickening components such as a sodium alginate or cellulose derivative or silicate or equivalent in the amount preferably between 0.5 and 15% by weight (see page 13/24 of translation, paragraph seven)(limitations of claim 1e and claim 12).
Further regarding the amounts of components of claim 1c and 1d, it is not apparent that Nielsen necessarily teaches these amounts nor is it apparent that Nielsen teaches an embodiment in which retinol in particular is employed in encapsulated form as further described in claim 13. Garces cures this deficiency. Garces further teaches features of at least instant claims 4, 9-11.
Garces teaches microcapsules comprising active agents for use in cosmetic products including emulsions, gels, fatty compositions, and similar formulations wherein microcapsules may be incorporated to structure the formulations so as to protect the active agent (see Garces claims 1 and 10 and Garces [0069]). Retinol is named among the active agents which may desirably be protected in microcapsules (see [0026] and Example 1 for instance [0072]). Further regarding the nonionic emulsifier component of claim 1c and 13c, Garces teaches emulsifiers including nonionic ones (see [0038],[0039]) wherein polyglyceryl-3 methylglucose distearate is named as a state of the art polyglyceryl ester and further teaches polyglyceryl-3 disostearate (see [0058]) (limitation of claim 13c) wherein these emulsifiers are disclosed to be employed preferably in the range of 2 to 8% by weight of the formulations (see [0058],[0059])(limitation of claims 1c and claim 4). Further regarding the fatty phase component claim 1d as further detailed in claims 5-9, Garces teaches in Table 1 the C12-C15 alkyl benzoate in an amount of 2.0, 3.0, and 6.0% by weight of the total composition (see example Compositions 32, 34, 37, and 40 in particular) (limitations of claims 5-9).
As to claim 1f, Garces generally teaches cetearyl alcohol for instance (see Table 1) as well as the one or more water soluble solvents instantly recited (see [0069] and Table 1), however neither Nielsen nor Garces limits the polyol to be included to glycerin or glycol or suggests an amount within the instantly claimed range of about 12 to about 25%.
Simon cures this deficiency. It is noted that Nielsen cites Simon for its teachings of cosmetic and/or dermatological preparations in the form of transparent gels which contain at least one polyol, and Garces incorporates Simon by reference. See paragraph starting “The document EP 839520…” in translation; the Simon reference cited here is the English language equivalent to the Nielsen’s referenced document. Simon teaches rinseable skincare compositions containing a polyol component (see title and abstract, in particular). Simon teaches that the polyol may be for instance glycerol (see column 4, lines 20-25) and preferably is present in an amount of from 0.5 to 60% and most preferably from 5 to 30% by weight of the total composition including for instance a value which is 15% by weight polyol (see column 4, lines 29-34).
Both Nielsen and Simon are directed to cosmetic compositions in emulsion form. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to adjust the polyol, glycol, component in Nielsen, to an amount suggested by Simon, with a reasonable expectation of success. One would have been motivated to do so in view of Nielsen’s reference to Simon and furthermore based on Simon’s teaching that the polyol component may be employed in such an amount and in order to provide the polyol’s contribution to an emulsion which is a cosmetic vehicle for typical application to the skin.
Further regarding component 1b and claims 2 and 13, as well as claims 23 and 24, Nielsen’s formulations include polyacrylates or polyacrylic acids (see page 11 of translation, paragraph 2) but do not specify the instantly specified sodium polyacrylate and amount thereof.
Weisman cures this deficiency. Weisman teaches formulations comprising retinol, emulsifiers, and polymer components for instance (see Example 1, [0065]-[0066]). Weisman recommends sodium polyacrylate between about 1 and 2% by weight of a total formulation and exemplifies sodium polyacrylate in an amount of 1.43% by mass of a final product (see Table 30.0)([0117]). This component is included for its function as a preferred liquid dispersion polymer (see Weisman claim 4 and [0036] in particular).
Nielsen and Weisman are both directed to retinol containing emulsions. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to add sodium polyacrylate in an amount of 1 to 2% by weight of a total emulsion as taught and exemplified by Weisman in the formulations of Nielsen, with a reasonable expectation of success. One would have been motivated to do so to provide good and optimizable liquid dispersion effects from the inclusion of this component in an emulsion as taught by Weisman.
The limitations of claims 13 and 17-20 have been addressed above in regard to the limitations of claims 1-10. It is noted that Garces teaches tocopherol microcapsules (see Table 1 and Example 3 at [0074] in particular).
Both Nielsen and Garces are directed to carrier formulations including emulsions for the storage and delivery of cosmetic active agents including retinol. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to encapsulate retinol as taught by Garces in the formulations of Nielsen and to add specific amounts of components as suggested by Garces for the formulation of components taught by Nielsen and/or Garces in the analogous formulations in the absence of Nielsen’s specification of amounts, with a reasonable expectation of success. One would have been motivated to look to the guidance of Garces in doing so to facilitate good formulation and/or carrier benefits or stabilization effects as is customary in the art with regard to functional adjuvants and as further specified by Garces.
Further regarding claims 21 and 22, Nielsen teaches isononyl isononanoate among ester oils which may be included (see last paragraph on page 7/24 of translation) such that one reasonably would have expected success from including this component. As to the teaching of caprylic/capric triglyceride newly recited in claims 21 and 22, this component has been addressed above in regard to claims 1 and 13 as taught by Nielsen. Further regarding the additional claimed component which is glycine soja (soybean) oil as in claims 21 and 22, Nielsen also teaches this component (“Sojaol”) among ester oils which may be employed (see page 15/32, second paragraph from bottom of page, second line from end of that paragraph). Accordingly, one reasonably would have expected success from substituting any and all of these known oil and/or ester oil components one for another since the art reasonably establishes these as functional equivalents. One would have reasonably expected success from doing so since the art establishes these oils or fatty compounds as useful carriers in analogous formulations.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617