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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
Status of the claims
Claims 2, 3-4, and 11 have been cancelled in a previous communication.
Claims 1, 5-10, and 12 are currently under examination.
All rejections not reiterated have been withdrawn.
Terminal Disclaimer
A terminal disclaimer is on file for copending application no. 17/603,312.
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, 5-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (CN108685741A, Published 10/23/2018) in view Ferrari et al. (WO2017193186A1, Published 11/16/2017; cited in the IDS filed 10/12/2021) further in view of Kropke et al. (US20040258722A1, Published 12/23/2004).
Applicant’s invention
The applicant’s claims are drawn to a cosmetic complex comprising the following ingredients: Fevillea trilobata seed crude oil in an amount of 8% to 17% by weight, trehalose in an amount of 28% to 52% by weight; and sodium hyaluronate in an amount of 4% to 17% by weight, and 34% to 43% by weight betaine.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 1, Yu teaches a composition for promoting skin barrier repair comprising the following parts by weight: trehalose 10-20% by weight, sodium hyaluronate 10-30% by weight, Centella asiatica extract 5-15% by weight (paragraph 6). Yu also teaches the skin barrier is damaged, that is, the stratum corneum and sebum of the skin are damaged, and the stratum corneum and sebum membrane are damaged. The common causes are as follows: (1) excessive cleansing; (2) exfoliation; (3) mask Improper use; (4) abuse of corticosteroids; (5) cosmetic treatment such as laser treatment. The skin barrier is damaged, mainly as follows: (1) The skin's ceramide production is reduced, resulting in decreased skin moisturizing function, easy skin drying (paragraph 3).
Regarding claims 6 and 8, Yu teaches a composition for promoting skin barrier repair (i.e., topical cosmetic product) and an application thereof, which can be used for promoting repair after skin barrier damage (paragraph 4). Yu also teaches an external preparation such as an emulsion, a paste or a gel, which is applied to the damaged skin after the skin is cleaned (paragraph 11). Yu further teaches The skin has a higher transepidermal water loss after the skin barrier is damaged, and the stratum corneum has a lower water content. After treatment, the skin barrier function of both groups was improved (i.e., moisturizing the skin) (results paragraph).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Yu does not teach Fevillea trilobata seed crude oil. Yu also does not teach betaine and sorbitol. However these deficiencies are cured by Ferrari et al and Kropke et al.
Ferrari et al. teaches a skin-repairing cosmetic compositions comprising at least one oil
selected from Fevillea trilobata (page 1, paragraph [1]). Regarding instant claim 10, Ferrari continues to teach the composition provides treatment of dry skin (paragraph [16]), which are suitable for both facial and body use (paragraph [17]). Regarding instant claims 6 and 8, Ferrari teaches applying the skin repairing cosmetic composition to the skin, body, or face an effective amount (claim 6).
In the analogous art of cosmetic preparations, Kropke teaches cosmetic and/or dermatological preparations comprising a) polyols in a concentration of 5 to 50% by weight,
b) betaines in a concentration of 0.01 to 75% by weight (abstract). Kropke also teaches (a) from 5% to 20% by weight of one or more polyols which comprise at least one of sorbitol (claim 27).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of
the invention to use Fevillea trilobata oil in Yu’s composition for promoting skin barrier repair which comprises sodium hyaluronate, and trehalose. Yu teaches a composition which is intended to promote skin barrier repair, wherein the skin barrier is damaged, mainly as follows: (1) The skin's ceramide production is reduced, resulting in decreased skin moisturizing function, easy skin drying (paragraph 3). One having ordinary skill in the art would have understood in view of Ferrari that a composition comprising Fevillea trilobata oil is good for the treatment of skin regeneration and healing as well as treatment of dry skin. Therefore, the artisan of ordinary skill would have been motivated to add Fevillea trilobata oil from Ferrari’s composition to Yu’s composition to take advantage of the benefit of the biological activity related to skin regeneration/repair (paragraph [0040]). The skilled artisan would have had a reasonable expectation of success because both Yu and Ferrari teach cosmetic compositions for skin repair. Regarding the ranges of the Fevillea trilobata seed crude oil, it would have been obvious to optimize the amount that is used in the composition because it is obvious to find the effective amount of the active agents to achieve optimal moisturization and skin repair and to vary range amounts depending on the desired result. Where 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, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art before the time of filing to use Fevillea trilobata oil in Yu’s composition for promoting skin barrier repair which comprises sodium hyaluronate, and trehalose. Yu teaches that the composition for promoting skin barrier repair comprises the following parts by weight: trehalose 10-20% by weight, sodium hyaluronate 10-30% by weight, Centella asiatica extract 5-15% by weight (paragraph 6), and is used to promote skin barrier repair, supplemented by trehalose, centella extract to enhance its repair of damaged skin barriers (paragraph 15). One would have understood in view of Ferrari that a skin repair composition comprises at least one oil selected from Fevillea trilobata (paragraph [14]). It would have been obvious to one of ordinary skill in the art use Fevillea trilobata oil in Yu’s composition for promoting skin barrier repair which comprises sodium hyaluronate, and trehalose because Yu teaches the use of Centella asiatica extract to help promote skin barrier repair (paragraph 15) and Ferrari teaches that Fevillea trilobata oil can be used for skin repair, therefore, one can substitute the 5-15% Centella asiatica extract with Ferrari’s Fevillea trilobata oil because both are known to help promote skin barrier repair. See MPEP 2144.06(II).
It would have been prima facie obvious to one of ordinary skill in the art before the time of filing to add betaine and sorbitol to Yu’s composition for promoting skin barrier repair which comprises sodium hyaluronate, and trehalose. One would have understood in view of Kropke that The skin is the largest human organ. Among its many functions (for example for heat regulation and as a sense organ), the barrier function, which prevents the drying out of the skin (and thus in the final analysis of the entire body), is probably the most important (paragraph [0003]). One of the most important objects of skincare, however, consists in moisturizing the skin. The classic skin moisturizing agents include, inter alia, polyols such as glycerol and sorbitol (paragraph [0006]). These preparations are distinguished by a pleasant less sticky less greasy skin sensation without the good skin-moisturizing properties being lost (paragraph [0015]). It would have been obvious to add betaine and sorbitol to Yu’s composition for promoting skin barrier repair which comprises sodium hyaluronate, and trehalose because Kropke teaches the use of betaine and sorbitol to moisturize the skin by preventing drying out of the skin which also affects the skin barrier function and Yu teaches repairing the skin barrier, therefore, the composition of Kropke comprising betaine and sorbitol are known for the same purpose as Yu’s composition for promoting skin barrier repair. See MPEP 2144.06 (I).
With regards to the limitation of claim 1, wherein trehalose is in the amount of 28% to 52%, Yu teaches a composition for promoting skin barrier repair comprising the following parts by weight: trehalose 10-20% by weight, the examiner points out that trehalose taught at 20% by Yu is merely close to the instantly claimed range of 28% by weight. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I).
With regards to the ratio recited in claim 5, it would have been obvious to optimize the amounts that are taught by Yu and Krokpke’s compositions of trehalose, sodium hyaluronate, and betaine because it is obvious to find the effective amount of the active agents and to vary range amounts depending on the desired result to achieve the desired ratio as claimed. Where 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, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
With regards to claim 6 and 8, which recites an active method of applying the cosmetic complex, it would have been prima facie obvious to apply the composition of Yu and Ferrari because Yu also teaches an external preparation such as an emulsion, a paste or a gel, which is applied to the damaged skin after the skin is cleaned (paragraph 11) and Ferrari teaches applying the composition to the skin, body, or face an effective amount (claim 6).
With regards to claims 7 and 9, this claim recites an intended use of the complex. The composition of Yu and Ferrari would be suitable for this use of preserving the skin natural microbiota because the instant specification teaches that trehalose maintains and balances skin microorganisms and helps to strengthen the skin barrier (page 8, lines 6-7) making it an inherent property of the composition.
Response to Arguments and Declaration
Applicant's arguments and Declaration filed 03/02/2026 have been fully considered but they are not persuasive.
On pages 3-4 of Applicants remarks, Applicants incorporates by reference the remarks regarding Figs. 1 and 2 from the Amendment filed on September 18, 2024 in connection with the instant application, wherein by analyzing Figures 1 and 2, it is possible to observe the benefits of active hydration, involving the modulation of gene expression, which differs from hydration by occlusion and by humectation, which depends on the formulation applied to the skin to provide hydration. Applicants further argue that the Declaration discloses the results of protein tests to show that the isolated use of the active ingredients is not capable of modulating the five mechanisms for active hydration and achieving the technical effect obtained by the combination of three of the four active ingredients claimed in the cosmetic complex of the invention.
These arguments are not persuasive. First, the examiner points out that Fig. 1 and Fig. 2 does not provide enough information to evaluate any unexpected nature of the data and is not clear what the data actually represents. The modulation of what specific genes are being accounted for and it is unclear how the modulation of the general genes translate to an effect on the skin. Thus the practical significance of the data describing some abstract modulation of genes is not clear. The examiner further points out that the placebo composition described in the specification on page 10 comprises different ingredients compared to the final complex, therefore the examiner cannot determine the unexpectedness of the final formula if the ingredients of the final formula and the placebo are different. Too many variables have been altered to evaluate which substance(s) in the composition according to the invention are responsible for any alleged improvement over a “placebo”. The examiner continues to point out that it is not clear how with the lipid synthesis, Sodium hyaluronate is not significant at a percentage of 21.5% but it is significant with Fevillea trilobata oil at a percentage of 21.4% when the percentage of Fevillea trilobata is less than the percentage of Sodium hyaluronate. The examiner also points out that the question is not whether the active ingredients individually have a different effect, as the different effects would be the exact reason why one would want to add all the active ingredients together into one formulation, even though all the ingredients are explicitly taught for the purpose of hydration. One would explicitly add the ingredients together because they have different mechanisms of action and would expect them to have these effects. Applicants have not shown that there is not anything more than an additive effect of combining all of the ingredients to provide hydration. The fact that Applicants have found that each ingredient works on a different mechanism is not given patentable weight. The examiner further points out that Applicants have not provided a side-by-side comparison to the closest prior art, wherein Yu teaches a composition for promoting skin barrier repair comprising the following parts by weight: trehalose 10-20% by weight, sodium hyaluronate 10-30% by weight, Centella asiatica extract 5-15% by weight (paragraph 6), which is two out of the four active ingredients in instant claim 1. Therefore, Applicants must show how when the other two active ingredients are added to the formulation of Yu they provide a better result than the one taught in Yu et al.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614