DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 6/1/2026 wherein claims 2-5, 8-10, 12-14, 16 and 17 have been amended and claims 1, 6, 7, 11, 18 and 19 have been cancelled.
Claims 2-5, 8-10 and 12-17 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 6/1/2026 overcome the rejection of claims 1-14 and 16-19 made by the Examiner under 35 USC 103 over Puche et al. (WO 2022/029579), evidenced by Applicant’s specification. This rejection has been withdrawn as the dropper coupled to the bottle is to have specific dimensions which are not described by the reference.
Applicant’s amendments filed 6/1/2026 overcome the rejection of claim 15 made by the Examiner under 35 USC 103 over Puche et al. (WO 2022/029579), evidenced by Applicant’s specification, further in view of Choi et al. (US 2021/0229879). This rejection has been withdrawn for the reasons noted under section 3 above.
New Rejections, Necessitated by Amendment
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 2-5, 8-10 and 12-17 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, in view of Choi et al. (US 2021/0229879; of record) and Asa et al. (US 4917274).
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 15). 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 15). 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 15.
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 12(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 15). 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 15). 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 15) 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 slope of the composition as recited by instant claims 8, 9 and 15, these properties are presumed present given the overlap between the claimed and prior art composition. Specifically, Puche describes compositions which contain 0.42wt% microcrystalline cellulose, 0.08wt% cellulose gum and 0.20wt% diutan gum (see Example 11, for example) which amounts to a total of 0.7wt%. Similarly, the present invention describes compositions that employ the same emulsion mixture (microcrystalline cellulose, cellulose gum and diutan gum) in an amount of 0.7wt% (see Examples D-F) which yields compositions with viscosities such as that claimed. Compare instant example D:
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to Example 11 of Puche
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. . The major difference is the presence of the 0.5wt% polyglyceryl-3 in the prior art composition. However, this is within the scope of ‘substantially free’ as the instant specification defines ‘substantially free’ as being present in an amount of less than 2wt% (see [0104] of published application). Thus, as the compositions of the prior art are substantially the same as that claimed, it’d be reasonable to expect the compositions to have overlapping properties, absent evidence otherwise. 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. As they are optional, they are not required. As such, one of ordinary skill in the art would envisage a composition that is 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.).
Puche fails to teach the composition as being contained in a bottle having a dropper coupled thereto wherein the dropper comprises a bulb and pipette coupled to the bulb, the pipette comprising i. a tip having a length LT and an internal diameter DT; and ii. a tube having a length LU and an internal diameter DU, wherein LT is from about 3 mm to about 12 mm, LU is about 55 mm to about 80 mm, DT is about 1 mm to about 2.3 mm, and Du is about 4 mm to about 6 mm.
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 according to the following figure:
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(see Figure 2 and abstract). Choi is silent regarding the dimensions of their dropper.
Asa is directed to a fluid dispenser tip having a tube with an elongated constant diameter small bore disposed at the outlet end thereof with a fluid reservoir disposed at the opposite internal end thereof (see abstract). The length of the dispenser is to be about 6.5 cm (65 mm) with the tip being 1.5 cm (15 mm) (see claim 5). The diameter of the tip is to narrow wherein dispensing end has a narrower diameter than the retaining section of the dispenser, the diameter of the wider section is to be 7 mm and narrow to between 0.3-1 mm (see column 2, lines 50-65). It is taught that such dimensions provides an improved control over the control of dispensing the displaced fluids. It would have been obvious to modify Choi’s dropper to utilize such dimensions with a reasonable expectation for success in providing improved control over the release of the skin care composition. It is also important to note that changes in the shape and size of the dropper are generally considered obvious targets to manipulate to ones’ desires. See MPEP 2144.03(IV)(A) and (B).
It would have been obvious to provide the composition of Puche in a bottle system such as that described by Choi together with a dropper having the dimensions/parameters described by Asa 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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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