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 .
Applicant’s arguments, filed 08/14/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9 and 12-21, stand rejected under 35 U.S.C. 103 as being unpatentable over Abe et al (US 20100209364 A1), in view of Horiuchi et al (JP 2006239666 A, pre-publication of JP 3855203) and Homma et al (JP 2015007014 A), as evidenced by Miura et al (US 8105630 B2) and SELECT BOTANICAL (Dipotassium Glycerrhizinate Technical-Scientific report, 2014).
Abe et al teaches emulsified compositions for the skin comprising 15 and 20 wt% of petrolatum, 20 wt% of glycerin, 1.5 wt% of lecithin (amphiphilic phospholipid), 0.2 wt% of xanthan gum (polycondensation polymer having a hydroxyl group), 0.15 wt% of prednisolone valerate acetate (a steroidal active agent), and the balance water (abs, ¶¶ 8, 15-16, 87, table 11 ex. 9, table 12 ex. 19-21). Prednisolone valerate acetate has a water solubility at 25 deg C of 4.0 μg/mL, as evidenced by Miura et al (col 2 lines 57-58), resulting in water solubility of 0.004 g/kg (water-insoluble). Abe et al teaches additional embodiments of the emulsified compositions comprise dipotassium glycyrrhizinate at 0.05 wt% and 0.1 wt%, as the active (table 11 ex. 14 and 12, respectively). As evidenced by SELECT BOTANICAL, dipotassium glycyrrhizinate is soluble in water. The aqueous phase is generally from 40 wt% or more in the oil-in-water emulsion, but typically ranges between 40 to 75wt%, based on the total weight of the emulsified compositions (¶¶ 42, 146). The petrolatum used are semi-solids (¶ 26). The emulsified compositions, such as emulsions and creams, are used as bases, where they are applied to the user’s skin (¶ 3). The emulsified compositions may be used in cosmetics or medicaments (¶ 161). Abe et al further teaches the compositions were prepared where petrolatum and lecithin were mixed together and heated, water was mixed separately with glycerin, heated, and then added to the petrolatum lecithin mixture, where it was then emulsified; the emulsion was then mixed with xanthan gum dissolved in the remaining amount of water (¶ 171). The emulsified compositions comprising petrolatum can be used as a base applied to users skin (¶¶ 2-4). The emulsified compositions have an average particle diameter of not more than 5000 nm (i.e., not more than 5 microns) (¶¶ 11, 134).
Abe et al does not specifically disclose that lecithin or xanthan gum forms vesicles or particles at the interface between the phases, an embodiment where the water insoluble functional component is added as an additional inner phase component, an embodiment as instantly claimed with a water soluble functional component, the specific methods of claims 12 and 13, specifically disclosing an ointment, nor an embodiment with the average particle size as instantly claimed.
Horiuchi et al teaches dispersed closed vesicles formulated by an amphiphilic substance via a three-phase emulsion, which was shown to have excellent stability over time at the interface between a functional oil base and water, or between functional granules and water, compared to conventional two-phase emulsions (¶¶ 5, 6, 17). The emulsions can be emulsified and dispersed regardless of the required HLB value of the oil to be emulsified or the surface state of the functional granules, which minimizes the trouble and labor of selecting an appropriate emulsifier (¶¶ 6, 20). The amphiphilic compound exists as an independent phase (¶ 6). Lecithin is taught to be a suitable phospholipid (amphiphilic compound) (¶¶ 35, 39, 60). The biopolymer solution was prepared by dispersing the biopolymer in water, allowing it to swell, followed by heating. The components were added drop-wisely to water while stirring (¶¶ 17, 42, 43).
Homma et al teaches cosmetic preparations having an O/W type emulsion structure using closed vesicles of an amphiphilic substance or particles of a polycondensation polymer having hydroxyl groups with high emulsion stability and suppression of the rough feel of the cosmetic preparation (¶¶ 1, 7). The closed vesicles or polycondensation polymers are present at the interface between the oil phase and aqueous phase (¶ 8). Ceramide 3, known to be particularly poorly soluble (i.e., water insoluble functional component), was emulsified using the closed vesicles or polycondensation polymer, but could not be emulsified with conventional surfactants (¶¶ 25, 53). The cosmetic preparations comprising closed vesicles or polycondensation polymers scored higher in all sensory categories, including freshness, moist feeling, smooth feeling, and non-stickiness, compared to preparations comprising conventional surfactants (¶ 55).
Regarding particles at the interface between the phases, it would have been obvious to modify the emulsion of Abe et al by formulating a three phase emulsion comprising vesicles comprising an amphiphilic substance at the interphase between the oil and water phases and the functional component and the aqueous phase, where it was known from Horiuchi et al to have improved stability compared to two phase emulsions, where both are directed to emulsions with stability as the common goal.
Further, additional motivation for including polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance at the interface between the phases is provided by Homma et al, where they were known to form stable emulsions of poorly soluble actives, where conventional surfactants cannot, and where the polycondensation polymers and/or vesicles improve the sensory properties of cosmetic preparations, including freshness, moist feeling, smooth feeling, and non-stickiness compared to conventional surfactants. Therefore, it would have been further obvious to modify Abe et al to include polycondensation polymers and/or vesicles as instantly claimed, for the above mentioned benefits.
Regarding the viscosity of the inner phase, where the instant claim recites the petrolatum can be liquid or semi-solid, where the liquid is 5000 mPas or more at 25 deg C, it appears that “semi-solid” petrolatum, as taught by Abe et al, would have a greater viscosity than liquid, i.e., greater than 5000 mPas at 25 deg C. Even if not, where Abe et al teaches semi solid petrolatum is used in an emulsified composition with a viscosity that varies between 500 and 30,000 mPas, a skilled artisan would reasonable be expected to adjust the viscosity of the petrolatum inner phase in order to achieve desired viscosity for various forms and applications. See MPEP 2144.05.
Regarding the O/W type emulsion structure, where the emulsion taught by Abe et al above is an oil in water (O/W) emulsion, and where O/W emulsions are taught to be suitable by Horiuchi et al and Homma et al, it would have been obvious to formulate emulsions with an O/W emulsion structure, as instantly claimed.
Regarding the additional inner phase of water insoluble functional of claim 1, it would have been obvious for a skilled artisan to formulate the emulsion made obvious above by including the water insoluble functional component as an additional inner phase, where multiple phase emulsions were known from Horiuchi et al. Further, it was known that the vesicles of Horiuchi et al can be present at the interface of the functional component, and it would therefore been obvious to include an additional inner phase of functional component in order to be stabilized by the vesicles and improve the feel of the formulation, as taught by Homma et al.
Regarding the oil phase with the water insoluble functional component of claim 2, where Abe et al appears to teach a two phase emulsion, it appears that the water insoluble functional component would be included in the oil phase. Therefore, when formulating the three phase emulsion discussed above, it would have been obvious to include the water insoluble functional component into the oil phase in order to solubilize the functional component.
Regarding claims 3 and 16, prednisolone valerate acetate (water insoluble functional component) is included in the embodiment of Abe et al cited above at 0.15 wt%, which is less than 50% by mass as instantly claimed.
Regarding claims 4, 7, and 17, where Abe et al teaches the emulsions may be used as medicaments or cosmetics, it appears that the water-insoluble and water-soluble functional components of Abe et al are functional components of cosmetics and/or pharmaceuticals, as instantly claimed.
Regarding claim 5, where Abe et al teaches the emulsions can comprise dipotassium glycyrrhizinate (a water soluble functional component), it would have been obvious to formulate an emulsion with an oil phase consisting of petrolatum as an inner phase, and aqueous phase as an outer phase, and to include the water soluble functional component in the aqueous phase in order to solubilize the functional component, as taught by Abe et al, and include particles of a polycondensation polymer and/or vesicles at the interface of the phases as instantly claimed, as taught by Horiuchi et al and Homma et al, for the reasons discussed above, thus arriving at the claimed invention.
Regarding claim 6, it would have been obvious to include dipotassium glycyrrhizinate in amounts from at 0.05 wt% and 0.1 wt%, as taught by Abe et al, falling within the claimed range.
Regarding claims 8, 18, and 19, where the aqueous phase of Abe et al ranges between 40 and 75 wt%, the oil phase is less than 70wt%.
Regarding the wt% of petrolatum of claims 9, 20, and 21, it would have been obvious to formulate the emulsions of Abe et al comprising petrolatum in an amount of 15 to 20 wt%, as taught by Abe et al, falling within the claimed range.
Regarding claim 12, where Abe et al teaches the oil phase and the aqueous phase are mixed, as well as embodiments comprising water-soluble or water-insoluble functional components, it would have been obvious to add and mix the functional components with the emulsion made obvious above, comprising petrolatum as the oil phase, an aqueous phase as an outer phase, and the polycondensation polymer and/or vesicles of Horiuchi et al (i.e., the base), for the same reasons discussed above.
Regarding claim 13, where the oil phase comprising a water insoluble functional component and aqueous phase are combined, heated, and mixed, it would have been obvious for the skilled artisan to add the components, including the vesicles or polycondensation polymers, through any method, including drop-wisely, as taught by Horiuchi et al, and mixed in any order, to arrive at the same emulsion composition. See MPEP 2143(I)(D) and 2144.04(IV)(C).
Regarding claim 14, where the emulsion composition made obvious above comprises petrolatum as the oil phase, an aqueous phase as an outer phase, and polycondensation polymer and/or vesicles at the interface between the oil and aqueous phases, it would have been obvious to formulate the above composition as a “base” for the addition of a functional component, and where Abe et al teaches the emulsions can be used a base, and where embodiments comprising functional components are disclosed.
Regarding claim 15, it appears the form of being an ointment is an inherent characteristic of the composition. See MPEP 2112(III).
Response to Arguments
First, Applicants assert that it is respectfully not seen where the cited reference teaches or suggests the structure of claim 1. Applicants assert that the claimed invention emulsifies petrolatum having high viscosity stably by a three phase emulsion technique, and adds the water-insoluble component/the water-soluble component to the emulsified composition as a base. Second, Applicants assert Abe et al teaches a smaller particle diameter than instantly claimed that is produced by a phase inversion technique. Applicants assert the smaller particles are for stability of the petrolatum. Applicants also assert that the small emulsion particles of Abe et al cannot be produced by the emulsion technique instantly claimed, and that in past publications of Horiuchi, there are no publications teaching a method for producing small emulsions such as Abe et al, and there are not teachings of stably emulsifying a high viscosity oil like petrolatum. Third, Applicants asset the average particle diameter of not more than 5000 nm, was measured based on Mie theory, and the reference teaches not more than 800 nm, and preferably not more than 500 nm when measured by dynamic light scattering method.
First, respectfully, this argument is not persuasive. As discussed above and of record, Abe et al teach O/W emulsions comprising petrolatum as an oil phase, a water-insoluble or water-soluble functional component, and an aqueous phase, wherein the viscosity of the petrolatum appears to be substantially the same or overlaps the claimed viscosity range. Horiuchi et al and Homma et al provided motivation to modify the emulsion of Abe et al by including particles of a polycondensation polymer at the interface between the phases for purposes of improved stability, etc. Additionally, Horiuchi et al provides motivation to include the water-insoluble functional component as an additional inner phase, where the polycondensation polymers were known to form at the interface of the oil phase and water, and at the interface of the functional component phase and water, providing stability, smooth feeling, etc., as discussed above. As such, contrary to Applicants' assertion, it appears that the combination discussed above makes obvious the structure as instantly claimed.
Additionally, Applicants assert the components are added to an emulsified composition as a base in claim 1, however, claim 1 simply recites the product by process limitation where the oil phase and water-insoluble functional component are added to the aqueous phase and emulsified. Even if a "base" was required by claim 1, an emulsion base for adding the functional components are made obvious above by Abe et al and for the same reasons. As discussed above, the selection of any order of mixing ingredients is prima facie obvious. See 2144.04(IV)(C).
Second, respectfully, this argument is not persuasive. Applicants assert that the smaller particles of Abe et al cannot be produced by the emulsion structure as instantly claimed, which is made obvious above by Abe et al, Horiuchi et al, and Homma et al, however, there do not appear to be any teachings or suggestions in Horiuchi et al that limits the particle diameter of the disclosed three phase emulsion structure, let alone teaching that particle diameters of Abe et al are not possible to obtain. Additionally, Applicants have not provided any objective evidence or an explanation as to why the three phase structure cannot have a particle diameter within the range taught by Abe et al. Attorney argument does not replace evidence where evidenced is necessary. See MPEP 2145(I). Applicants assert that past publications of Horiuchi et al have not disclosed particle diameters as small as those of Abe et al, however, past publications of Horiuchi et al, other than the one cited, are not included in the prior art rejection.
Third, this argument is persuasive. Applicants have newly amended instant claims 22-27 to recite that the average particle diameter is the average particle diameter when measured by dynamic light scattering. While Abe et al teaches particle diameters of not more than 5000 nm are suitable, these particle sizes were measured based on Mie theory, and the reference explicitly teaches that when measured by dynamic light scattering, the particles are not more than 800 nm. Abe et al further teach that if the average particle diameter exceeds 800 nm as measured by dynamic light scattering, the emulsified compositions deteriorate sense of use and stability (¶ 141). As such, there does not appear to be motivation to increase the particle size from not more than 800 nm (i.e., not more than 0.8 microns), to the newly amended average particle diameter range of 4-20 microns as measured by dynamic light scattering.
Claims 1-9 and 12-27, are rejected under 35 U.S.C. 103 as being unpatentable over Sonti et al (US 20160338973 A1), in view of Abe et al (US 20100209364 A1), Horiuchi et al (JP 2006239666 A, pre-publication of JP 3855203) and Homma et al (JP 2015007014 A).
Sonti et al teach topical pharmaceutical oil-in-water (O/W) emulsions comprising 3,5-dihydroxy-4-isopropyl-trans-stilbene (functional component), an oil phase, and a water phase (abs, ¶ 197). In embodiments, the oil phase is petrolatum (¶ 197). The active is water-insoluble and may be solubilized in the oil phase, or may be combined with a co-solvent to solubilize the active ingredient in the water phase (¶¶ 22, 43, 44). When the aqueous phases is added to the oil phase, the active ingredient can be soluble in both the aqueous and/or the oil phase depending on where and how much of the co-solvent(s) partition into the system (¶ 198). The active phase, oil phase, and aqueous phases are formulated separately; the oil phase is heated, added to the aqueous phase and mixed; the active phase is then added and mixed into the combined oil and aqueous phases (¶¶ 328-344). The amount of active ingredient in the oil phase may be greater than or equal to 50 wt%, and the amount of active ingredient in the aqueous phase may be greater than or equal to 10 wt% (¶¶ 43-44). The active agent may be present in the composition in a range from about 0.25 to about 2 wt% (¶ 196). The oil phase comprises an oil in an amount from about 5 wt% to about 45 wt%, based on the total weight of the composition (¶¶ 72, 159). In embodiments, the oil phase contains less than or equal to 3 wt%, greater than 3 wt%, greater than 5 wt%, greater than 10 wt%, and greater than 15 wt% petrolatum (¶¶ 158, 197). The average droplet size of the discontinuous phase is less than about 35 microns, less than about 25 microns, etc. (¶ 26). The formulation can be an ointment (¶ 136).
Sonti et al do not teach the viscosity of the petrolatum, an embodiment with a water-soluble functional component, nor particles of a polycondensation polymer at the interface of the phases as instantly claimed.
Abe et al are discussed above but do not teach particles of a polycondensation polymer at the interface of the phases as instantly claimed.
Horiuchi et al and Homma et al are discussed above.
Regarding the emulsion of claim 1, it would have been obvious to formulate an oil-in-water (O/W) emulsion comprising an oil phase comprising petrolatum, an aqueous phase, and a water-insoluble functional component (3,5-dihydroxy-4-isopropyl-trans-stilbene) in the oil phase, as taught by Sonti et al.
Regarding the additional inner phase of water insoluble functional of claim 1, it would have been obvious for a skilled artisan to formulate the emulsion made obvious above by including the water insoluble functional component as an additional inner phase, where multiple phase emulsions were known from Horiuchi et al, and the polycondensation polymer at the interface of the phases were known to stabilize oil and functional components. Further, it was known that the vesicles of Horiuchi et al can be present at the interface of the functional component, and it would have therefore been obvious to include an additional inner phase of functional component in order to be stabilized by the vesicles and improve the feel of the formulation, as taught by Homma et al.
Regarding particles of a polycondensation polymer, it would have been obvious to modify the emulsion of Sonti et al by formulating an emulsion comprising vesicles comprising an amphiphilic substance at the interphase between the oil and aqueous phase and the functional component and the aqueous phase, where it was known from Horiuchi et al to have improved stability and ease of selecting an appropriate emulsifier, when compared to two phase emulsions, where both are directed to emulsions with stability as the common goal.
Further, additional motivation for including polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance at the interface between the phases is provided by Homma et al, where they were known to form stable emulsions of poorly soluble actives, where conventional surfactants cannot, and where the polycondensation polymers and/or vesicles improve the sensory properties of cosmetic preparations, including freshness, moist feeling, smooth feeling, and non-stickiness compared to conventional surfactants. Therefore, it would have been further obvious to modify Sonti et al to include polycondensation polymers and/or vesicles as instantly claimed, for the above mentioned benefits.
Regarding the viscosity of petrolatum, it would have been obvious to select from known petrolatum viscosities suitable for emulsified compositions, such as between 500 and 30,000 mPas, as taught by Abe et al, in order to achieve desired viscosity for various forms and applications. See MPEP 2144.05.
Regarding the emulsion of claim 2, it would have been obvious to formulate an oil-in-water (O/W) emulsion comprising an oil phase comprising petrolatum, an aqueous phase, and a water-insoluble functional component (3,5-dihydroxy-4-isopropyl-trans-stilbene) in the oil phase, as taught by Sonti et al.
Regarding particles of a polycondensation polymer of claim 2, it would have been obvious to modify the emulsion of Sonti et al by formulating an emulsion comprising vesicles comprising an amphiphilic substance at the interphase between the oil and water phases and the functional component and the aqueous phase, where it was known from Horiuchi et al to have improved stability and ease of selecting an appropriate emulsifier, when compared to two phase emulsions, where both are directed to emulsions with stability as the common goal.
Further, additional motivation for including polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance at the interface between the phases is provided by Homma et al, where they were known to form stable emulsions of poorly soluble actives, where conventional surfactants cannot, and where the polycondensation polymers and/or vesicles improve the sensory properties of cosmetic preparations, including freshness, moist feeling, smooth feeling, and non-stickiness compared to conventional surfactants. Therefore, it would have been further obvious to modify Sonti et al to include polycondensation polymers and/or vesicles as instantly claimed, for the above mentioned benefits.
Regarding the viscosity of petrolatum, it would have been obvious to select from known petrolatum viscosities suitable for emulsified compositions, such as between 500 and 30,000 mPas, as taught by Abe et al for the same reasons discussed above.
Regarding claims 3 and 16, it would have been obvious to include the water-insoluble functional component in an amount from about 0.25 to about 2 wt% of the composition, as taught by Sonti et al, falling within the claimed range.
Regarding claims 4 and 17, where Sonti et al teach a water-insoluble functional component in topical pharmaceutical emulsions, the water-insoluble functional component is a functional comment of pharmaceuticals.
Regarding claim 5, it would have been obvious to modify the emulsion made obvious above by solubilizing the active agent of Soni et al in the aqueous phase, where Soni et al teach the active agent can be solubilized in the aqueous phase through the use of co-solvents. Where the active agent is solubilized in the aqueous phase with co-solvent, it appears the active agent reads on a water-soluble functional component. Even if not, where Sonti et al teach the active agent can be solubilized in the aqueous phase, it would have been obvious to include other water soluble active agents suitable for topical emulsion formulations comprising petrolatum, such as dipotassium glycyrrhizinate (a water-soluble functional component), as taught by Abe et al.
Regarding claim 6, where the active agent as a water-soluble functional component is made obvious by Sonti et al above, it would have been obvious to include the active in amounts taught to be suitable, such as from about 0.25 to about 2 wt% of the composition, as taught by Sonti et al.
Further, the inclusion of dipotassium glycyrrhizinate is made obvious above by Sonti et al and Abe et al, and it would have been obvious to include the active in amounts from at 0.05 wt% and 0.1 wt%, as taught by Abe et al, falling within the claimed range.
Regarding claim 7, where the active agent of Sonti et al is a component of a pharmaceutical composition and where dipotassium glycyrrhizinate is used in emulsions for medicaments or cosmetics, as taught by Abe et al, it appears that the functional components made obvious above are functional components of cosmetics and/or pharmaceuticals, as instantly claimed.
Regarding claims 8, 18, and 19, it would have been obvious to formulate the emulsion made obvious above with an oil phase content from about 5 wt% to about 45 wt%, based on the total weight of the composition, as taught by Sonti et al.
Regarding claims 9, 20, and 21, where Sonti et al teach the oil phase comprises petrolatum in amounts less than or equal to 3 wt%, greater than 3 wt%, greater than 5 wt%, greater than 10 wt%, and greater than 15 wt% petrolatum, and the oil phase content can be from about 5 wt% to about 45 wt%, it would have been obvious to select from petrolatum concentrations falling within the claimed range. For example, 5 wt% petrolatum at 45 wt% oil phase is equal to about 2.25 wt% based on the weight of the composition. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 12, where Sonti et al teach the oil phase and the aqueous phase are mixed, wherein the active agent is added to the emulsified oil phase and aqueous phase, it would have been obvious to mix the functional components with the emulsion made obvious above.
Regarding the base of claim 12, where the oil phase and aqueous phase are combined and mixed prior to adding the active agent phase, it appears that the mixed emulsion of the oil phase and aqueous phase reads on a “base” for adding the functional component, where the active agents are added to a base emulsion.
Regarding the polycondensation polymer of claim 12, it would have been obvious to include a polycondensation polymer as instantly claimed for the same reasons discussed above by Horiuchi et al and Homma et al.
Regarding claim 13, where Sonti et al teach the oil phase is heated and combined with the aqueous phase, and teach the water-insoluble active can be solubilized in the oil phase, it would have been obvious for the skilled artisan to add the components, including the vesicles of polycondensation polymers, though any method, including drop-wisely, as taught by Horiuchi et al. It would have also been obvious to mix the components in any order to arrive at the same emulsion composition. See MPEP 2143(I)(D) and 2144.04(IV)(C). Further, it would have been obvious to add the polycondensation polymer to the aqueous phase, as taught by Horiuchi et al.
Regarding claim 14, where the emulsion composition made obvious above comprises petrolatum as the oil phase, an aqueous phase, and polycondensation polymer and/or vesicles at the interface between the oil and aqueous phases, it would have been obvious to formulate the above composition as a “base” for the addition of a functional component, where Sonti et al teach mixing the oil phase and aqueous phase prior to the addition of a separate active agent phase.
Regarding claim 15, it would have been obvious to formulate the emulsion made obvious above as an ointment, thereby meeting the intended use limitation.
Regarding claims 22-27, it would have been obvious to formulate the emulsion made obvious above with a mean particle diameter of less than 35 microns, including less than 25 microns, etc., as taught by Sonti et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding wherein the particle size is measured by dynamic light scattering, the limitation is simply a product by process limitation where the size of the particles appear to be independent of the process of measuring.
Claims 22-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sonti et al (US 20160338973 A1), Abe et al (US 20100209364 A1), Horiuchi et al (JP 2006239666 A, pre-publication of JP 3855203) and Homma et al (JP 2015007014 A), as applied to claims 1-9 and 12-21 above, and further in view of Nakamura (US 20100272763 A1).
The reference are discussed above, and if somehow dynamic light scattering is required to measure the particle size as instantly claimed, the following applies.
Nakamura teaches oil-in-water external skin preparations, where dynamic light scattering was the preferred method of measuring particle size due to ease of measurement (abs, ¶¶ 25-26). Vaseline is disclosed as a suitable oil (¶ 50).
Regarding claims 22-27, it would have been obvious to formulate the emulsion made obvious above with a mean particle diameter of less than 35 microns, including less than 25 microns, etc., as taught by Sonti et al. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Further, it would have been obvious to use known methods of measuring particle size of oil-in-water emulsions, such as dynamic light scattering for its ease of measurement, as taught by Nakamura.
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 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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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600
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