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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/29/26 has been entered.
Claims 1-3, 5, 6, 9 and 12-24 are pending. Claims 16-24 are withdrawn. Claims 1 and 9 have been amended. Claims 1-3, 5, 6, 9 and 12-15 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 2, 5, 6, 9, 12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ramin et al. (US 2002/0012643) in view of De Oliveira et al. (Int. J. Adv. Biotechnol. Res., 2015; cited in IDS).
Ramin et al. teach compositions for removing make-up from keratinous materials, including nail polish removal compositions comprising a removal solvent (e.g. abstract; paragraphs 0002; Examples 1 and 2; Claim 46). Ramin et al. teach that the compositions can further comprise a surfactant (e.g. paragraph 0040-0057) and preservatives (e.g. paragraph 0071), but does not teach that the surfactant is a sophorolipid. This is made up for by the teachings of De Oliveira et al.
De Oliveira et al. teach that sophorolipids (SLP) are one of the most promising and attractive biosurfactants which combines green chemistry with lower carbon footprint, without the undesirable side products or environmental downsides associated with synthetic surfactants (e.g. page 161, column 2). De Oliveira teach that SLP have numerous properties that make them superior to synthetic surfactants including: stability in the wide range of pHs, temperatures, and salinity, low-foaming and excellent detergent properties, water hardness (high concentration of divalent cations) does not affect their interfacial properties, synergism between acidic and lactonic forms of SLP increase surfactants activities, are readily biodegradable and exhibit good surface activity (critical micelle concentration (CMC), surface tension and emulsification behavior). In addition, SLP can be produced in large quantities based on renewable resources, agro-industrial by-products and residues and easy and simplified product recovery (e.g. page 162, column 1). De Oliveira teach that SLP can act as an antibacterial agent, antialgal, antifungal, antimycoplasma, and antiviral agents (e.g. page 166, column 1). De Oliveira teach that SLPs are already in use for cosmetics (e.g. Table on page 163).
Regarding Claim 1, it would have been obvious to one of ordinary skill in the art at the time of filing to include the sophorolipids of De Oliveira et al. in the nail polish remover composition of Ramin et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Ramin et al. teach the addition of surfactants and preservatives, and one of ordinary skill would have been motivated in order to provide the benefits disclosed by De Oliveira et al. including stability, biodegradability, antimicrobial and production of large quantities based on renewable resources. In addition, neither the claim, nor the specification define “a fermentation broth”. However, De Oliveira et al. teach that SLP are produced from several microorganisms, which grow are known to grow in aqueous media, and Ramin et al. exemplify water in the compositions (i.e. a fermentation broth) (e.g. Example 1).
Regarding Claims 2 and 6, Ramin et al. teach that the solvent is an acetate and the composition further comprises glycerol (e.g. paragraph 0034, Examples 1; Claim 46).
Regarding Claim 5, the source of the acetate is a product-by-process limitation. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. In the instant case, an acetate, whether produced through biological fermentation or not, is structurally identical. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding Claim 9, Ramin et al. teach that the surfactant is present at 0-10 wt% or 0.5-5 wt%, which overlap with the claimed range (e.g. paragraph 0057). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claims 12, 14 and 15, Ramin et al. teach the composition comprises:
0-10 wt% or 0.5-5 wt% of a surfactant (e.g. paragraph 0057);
0-99 wt% or 20-98 wt% of solvent, and further exemplify 77.5 wt% ethyl acetate or 83.5 wt% acetone (e.g. paragraph 0032 and 0034; Examples 1 and 2);
2 wt% of glycerol (e.g. Example 1 and 2); and
0.1-30 wt% of an aqueous phase, and further exemplify 4 wt% water (e.g. paragraph 0070; Example 1).
The ranges of ingredients disclosed by Ramin et al. are within or overlap the claimed ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ramin et al. (US 2002/0012643) in view of De Oliveira et al. (Int. J. Adv. Biotechnol. Res., 2015; cited in IDS) as applied to claims 1, 2, 5, 6, 9, 12, 14 and 15, and further in view of Kitamoto et al. (Journal of Oleo Science; Jan 2022).
Regarding Claims 1, 2, 5, 6, 9, 12 and 14, the teachings of Ramin et al. and De Oliveira et al. are described supra. Ramin et al. teach that the composition can further comprise moisturizers (e.g. paragraph 0071). They do not teach the inclusion of mannosylerythritol lipids. This is made up for by the teachings of Kitamoto et al.
Kitamoto et al. teach that mannosylerythritol lipids (MELs) show excellent moisturizing effects on human skin and hair, with comparable performance to natural ceramides (e.g. abstract). Kitamoto et al. teach that biosurfactants are attractive practical alternatives to chemical surfactants because they are effective ingredients for cosmetic and personal care products, due to their favorable attributes of lower toxicity, antimicrobial activity, skin compatibility, and protective and surface moisturizing effects (e.g. page 6, Section 6.1). Kitamoto et al. teach that the costs of ceramides are still high, due to their limited availability in plants or their complicated synthetic and purification processes. Also, they are hardly soluble in water; which makes handling them very difficult. Considering the high productivity of MELs and their interfacial properties, MELs will be a practical and low-cost replacement for ceramides (e.g. page 7, column 1).
Regarding Claims 3 and 13, it would have been obvious to one of ordinary skill in the art at the time of filing to include the mannosylerythritol lipids (MELs) of Kitamoto et al. in the nail polish remover composition of Ramin et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results. One of ordinary skill in the art would have predicted success as Ramin et al. teach the addition of moisturizing ingredients, and one of ordinary skill would have been motivated in order to provide the benefits of lower toxicity, antimicrobial activity, skin compatibility, and protective and surface moisturizing effects, at lower cost as taught by Kitamoto et al.
Response to Arguments
Applicant's arguments filed 6/29/26 have been fully considered but they are not persuasive. Applicant argues that the claims are directed to a formulation that comprises both a sophorolipid and a culture media from which the sophorolipid is obtained as described in Example 4 of the specification. The generic teaching of DeOliveira does not teach or suggest the use of this specific combination.
This is not found persuasive. The claims are not limited to Example 4. Neither the claim, nor the specification define “a fermentation broth”. De Oliveira et al. teach that SLP are produced from several microorganisms, which grow are known to grow in aqueous media, and Ramin et al. exemplify water in the compositions (i.e. a fermentation broth) (e.g. Example 1). It is suggested that the claim be amended to reflect the presence of the specific compounds that comprise Applicants’ “fermentation broth”.
Applicant further argues that while Ramin generically suggests "surfactant" paragraph [0041] states: The surfactant can be of the anionic, nonionic or amphoteric type, but preferably of the nonionic type. (Emphasis added) Ramin prefers the use of a nonionic surfactants. Sophorolipids do not fit this category of nonionic surfactants. Applicant respectfully submits that there is some undue experimentation and no reasonable expectation of success of replacing the nonionic surfactant of Ramin with a sophorolipid as suggested by DeOliveira given the stated preferences of Ramin.
This is not found persuasive. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). As described supra, one of ordinary skill in the art would have predicted success as Ramin et al. teach the addition of surfactants and preservatives, and one of ordinary skill would have been motivated in order to provide the benefits disclosed by De Oliveira et al. including stability, biodegradability, antimicrobial and production of large quantities based on renewable resources. “When a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have obvious to have selected sophorolipid as the surfactant to arrive at compositions “yielding no more than one would expect from such an arrangement”.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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