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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2004 has been considered by the examiner.
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.
Claims 1-14 and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Puche et al. (WO 2022/029579; of record), evidenced by Applicant’s specification.
Puche is directed to an emulsifier composition comprising: microcrystalline cellulose (with an average particle size of 10-200 microns; see column 8, line 35; see instant claim 17), at least one biogum of microbial origin and, optionally, at least one cellulose ether or derivative thereof (see abstract and claim 1) (see instant claim 1(a)). The biogum is produced via microbial fermentation extraction (see page 5, lines 20-21), such as diutan gum which is isolated from fermented Sphingomonas (see instant claim 1(a)). The cellulose ether may be that of sodium carboxymethylcellulose (NaCMC) which is identified as cellulose gum (see column 12, line 15). The “emulsifier composition” will herein refer to the combination of microcrystalline cellulose, the biogum derived from Sphingomonas and cellulose gum and be considered sufficiently narrow to obviate instant claim 11.
The emulsifier composition is to possess microcrystalline cellulose and the biogum in a weight ratio of 1:2 to 4:1 (see instant claim 12(a)), the biogum extract and cellulose gum in a weight ratio of 1:10:1 (see instant claim 12(b)) and microcrystalline cellulose and cellulose gum in a weight ratio of 3-6:1 (see instant claim 1(c)). Resulting emulsions are to comprise from 0.2-1.5 wt.% of the emulsion composition (see claim 15) (see instant claim 13). See MPEP 2144.05(I)(A) regarding obviousness of overlapping ranges.
The emulsifier composition is to be used in stabilizing emulsions and are to possess an oil phase and a water phase (see abstract), such as oil-in-water emulsions that are characterized by a continuous aqueous phase and a discontinuous dispersed oil phase (see page 1, lines 23-25) (see instant claim 1). The emulsifier composition is to be combined with the aqueous phase of the composition and the resulting emulsion exhibit improved stability and rheology (see abstract and Example 1). The composition is to be transparent or translucent without separation of insoluble matter (see page 39, line 23-24), such a composition would be fairly characterized as “stable” (see instant claim 1), ‘clean’ (see instant claim 14) and ‘free of visible particles’ (see instant claim 16).
The emulsion is to comprise an oil phase, wherein the oil phase comprises an oil component such as mineral oil, avocado oil, coconut oil, etc. (see page 16, lines 17-35). It is noted that coconut, avocado and mineral oils are described as ‘emollients’ by Applicant’s specification (see [0066-0068]) (see instant claim 1(b)). Thus, the oils of Puche’s composition would have the property of being an ‘emollient’.
Puche teaches that the emulsions comprising the emulsifier composition may be formulated as a skin care product and include water-soluble (and/or water-insoluble) personal care ingredients (see column 25, lines 10-12) (see instant claim 1(a)) such as vitamins (e.g. vitamin C; see page 24, line 28) and anti-wrinkle agents like retinol and tocopherol (i.e. vitamin E) (see page 29, lines 8 and 12) (see instant claims 2 and 3). Regarding the phase to which the active partitions to (continuous or dispersed) would depend on the nature of the phase and the included active. However, as the prior art contemplates a continuous phase comprising a liquid carrier, the emulsifier composition and a skin care active such as retinol, the outcome of such a combination must be overlapping with that claimed despite being unrecognized by the reference.
Regarding instant claims 4 and 5, the limitation to “…wherein the composition comprises greater than or equal to 75% of the retinol and/or derivatives thereof remaining as compared to the amount of retinol and/or derivatives thereof at the time of manufacture according to the HPLC Method” is a product-by-process limitation as it describes the composition (content of retinol retain relative to time of manufacture) in terms of an outcome of the process of making. See MPEP 2113(I) which states that product-by-process claims are not limited to the manipulations of the step, only the structure implied by the steps, and in the current case the result would be a composition comprising a continuous phase having a polymer system, a liquid carrier and retinol as a skin care active.
Puche’s emulsion is to have a viscosity of 1000-4000 mPa∙s (1-4 Pa∙s) (see column 24, lines 14-16). Although Puche does not teach the viscosity or time weighted force area as recited by instant claims 6-9, given the overlap in overall viscosity as well as the overlap in the composition itself, the claimed properties would have been obvious. Moreover, one would endeavor to manipulate the viscosity of the composition to best suit the end needs See MPEP 2144.05(II)(A) which states that 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.
Regarding instant claim 10, it is noted that xanthan gum and hydroxyethyl cellulose are described as optional components for inclusion in to the composition. However, as they are optional, they are not required. As such, one of ordinary skill in the art would envisage a composition that is substantially free of their presence.
Regarding instant claim 18, Puche teaches a mixture of microcrystalline cellulose, biogum, cellulose gum, a liquid carrier comprising water and a preservative (phenoxyethanol) is described by Example 1. This mixture is not in the form of an emulsion. It would be obvious to supplement this mixture with a skin care active such as those mentioned above under section 7 (e.g. retinol, vitamin C, etc.).
The only difference between Puche and the instant claims is that Puche does not teach the specific combination of components as claimed in a single embodiment, or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Puche, but ‘such ‘picking and choosing’ within several variable does not give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, 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. See MPEP 2141(I). Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within Puche's teach to arrive at compositions such as those claimed.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Puche et al. (WO 2022/029579; of record) as applied to claims 1-14 and 16-19 above, and further in view of Choi et al. (US 2021/0229879).
Puche fails to teach the composition as being contained in a bottle having a dropper coupled thereto.
Choi is directed to a dropper dispenser for delivering skin care compositions. The dropper dispenser is in the form of a bottle having a dropper couple thereto (see Figure 2 and abstract). It would have been obvious to provide the composition of Puche in a bottle system such as that described by Choi with a reasonable expectation in said bottle system being a suitable means of delivery of Puche’s emulsified composition.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim Objections
Claim 7 is objected to because of the following informalities: appears to be missing an ‘and’ between “s-1” and “shear”. Appropriate correction is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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