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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/10/2026 has been entered.
Applicants' arguments, filed 03/10/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Status
Claims 1-9, and 12-27, are pending and under examination.
Claim Rejections - 35 USC § 112(b) or pre-AIA 2nd ¶
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 12, 14, 15-25, and 27, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5, 12, and 14, recite “the oil phase consisting of petrolatum or the oil phase is a liquid or semi-solid comprising petrolatum with a viscosity of 5000 mPas or more at 25 deg C,” and it is unclear if the viscosity limitation is the viscosity of the oil phase or the petrolatum. For purposes of examination, the limitation is interpreted as the viscosity of the petrolatum.
Claim 2 recites “the oil phase is a liquid or semi-solid comprising petrolatum and a water-insoluble functional component with a viscosity of 5000 mPas or more at 25 deg C,” and it is unclear if the viscosity limitation is the viscosity of the oil phase, the petrolatum, or the water-insoluble functional component. For purposes of examination, the limitation is interpreted as the viscosity of the petrolatum.
Claims 3, 4, 6-9, 15-25, and 27, are rejected for the same reasons above for depending upon rejected claims 1, 2, 5, and 14.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3, 4, 8, and 9, are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al (US 20100209364 A1), in view of Takakura et al (US 20110206627 A1, hereinafter “Takakura”), 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). Suitable active agents include UV absorbents, UV scattering agents, etc. (¶ 65).
Abe et al do not specifically disclose that lecithin or xanthan gum forms vesicles or particles at the interface between the phases, nor an embodiment where the water insoluble functional component is added as an additional inner phase component distinct from the oil phase.
Takakura teaches it was known to formulate cosmetic O/W emulsion compositions that are excellent in formulation stability, feeling in use, and UV protection ability, wherein the O/W emulsion comprises a first oil phase and a second oil phase dispersed separately in an aqueous phase (abs). Including the active agent in the first oil phase, separate from the additional oil phase, keeps the active agent stable without precipitation over time, where the active agent was poorly soluble in the silicon oil that was used (¶ 16). When the second oil phase is not incorporated, a sticky feeling is caused just after application (¶ 124). Emulsion particles sizes exceeding 700 nm also resulted in a sticky feeling and emulsion stability was not sufficient (¶ 124). The UV absorbing agent was dispersed in the first oil phase (¶ 51). The separate inner phases are emulsified using an emulsifier (¶ 16). The O/W emulsion cab further comprise liquid oils, solid oils, waxes, skin nutrients, vitamins, antioxidants , etc. (¶ 77).
Takakura do not appear to teach particles of a polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance present at an interface between the oil and aqueous phases.
Horiuchi et al teach dispersed closed vesicles formulated by an amphiphilic substance 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 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).
Similarly, 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 the composition of claim 1, Abe et al teaches emulsified compositions for the skin comprising petrolatum, water, etc.
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 Takakura 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 component of claim 1, it would have been obvious for a skilled artisan to formulate the emulsion made obvious above by including an additional inner phase as a separate inner phase distinct from the oil phase, where Takakura teaches it was known that providing O/W emulsions with multiple inner phases, where the active agent is dispersed in one of the inner phases, results in compositions that are excellent in formulation stability, feeling in use, and UV protection ability. Further, it would have been obvious to include the additional inner phase where it was known from Takakura that when two inner phases are not present, the formulations resulted in a sticky feel. Finally, where Takukura teaches that the active agent stability was increased when included in a distinct inner phase due to poor solubility in the other, the skilled artisan would have motivation to include an additional inner phase in order to optimize the solubility of the active agent, in order to keep the active agent stable without precipitation over time.
Regarding particles at the interface between the phases, it would have been obvious to modify the emulsion of Abe et al by further including vesicles comprising an amphiphilic substance at the interphase between the oil and water phases and the functional component and the aqueous phase, where these particles were known from Horiuchi et al to result in improved stability, where both are directed to emulsions with stability as the common goal.
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 Homma et al teaches polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance at the interface between the phases 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, it would have been further obvious to modify Abe et al to include polycondensation polymers at the interface between the phases 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 claim 3, 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 claim 4, 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 8, it would have been obvious to formulate the aqueous phase with known ranges taught to by suitable by Abe et al, such as between 40 and 75 wt%, thereby resulting in an oil phase that is less than 70 wt%.
Regarding the wt% of petrolatum of claim 9, it would have been obvious to formulate the emulsion composition made obvious above comprising petrolatum in an amount of 15 to 20 wt%, as taught by Abe et al, falling within the claimed range.
Response to Arguments
First, Applicants assert claim 1 has been amended to recite that the water-insoluble functional component is maintained as a separate inner phase distinct from the oil phase. Applicants assert that Abe et al teach the functional components dissolved in either the oil phase or the aqueous phase, wherein the functional component becomes a part of an existing phase, as required by the claims.
Second, Applicants assert Horiuchi et al do not disclose or suggest maintaining a water-insoluble functional component as a separate inner phase distinct from the oil phase, where the functional components are incorporated into an existing phase. Applicants assert that while Horiuchi et al teach polycondensation polymers being present at an oil-water interface to stabilize an emulsion and improve sensory properties, Horiuchi et al do not teach or suggest that such polymers stabilize two distinct inner phases.
Third, Applicants assert Homma et al do not cure the deficiencies of Abe et al and Horiuchi et al. Specifically, Applicants assert that Homma et al simply teaches cosmetic preparation in which poorly soluble functional components are solubilized within an oil phase, with vesicles or polycondensation polymer particles present at the oil-water interface to improve stability and sensory properties, but does not suggest maintaining the functional component as a phase distinct from the oil phase, nor suggest particles or vesicles simultaneously stabilizing multiple different interfaces within a single emulsion.
Fourth, Applicants assert the reconstruction is based on impermissible hindsight.
First, respectfully, this argument is not persuasive. In view of Applicants amendments to claim 1, Takakura is newly cited above for motivation to include an oil phase as an inner phase and a water-insoluble functional component as an additional inner phase, for the same reasons discussed above.
Second, respectfully, this argument is not persuasive. As noted above, Takakura is newly cited for motivation to include an oil phase as an inner phase and a water-insoluble functional component as an additional inner phase, for the same reasons discussed above.
Third, respectfully, this argument is not persuasive. As noted above, Takakura is newly cited for motivation to include an oil phase as an inner phase and a water-insoluble functional component as an additional inner phase, for the same reasons discussed above. Where the water-insoluble functional component as an additional separate inner phase is made obvious above, it would have been obvious to include particles of a polycondensation polymer at the interface between the phases of the water insoluble and aqueous phases, where it was known that these particles improve stability, sensory properties, etc., as discussed above.
Fourth, regarding Applicants argument of hindsight, In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, the combination made obvious above would have required no more than the teachings and motivation provided by each reference, and the knowledge that was within the relative skills of the skilled artisan at the time the claimed invention was made.
Claims 2, 5-7, and 12-21, are 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).
Abe et al are discussed above but do not specifically teach 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 and Homma et al are discussed above.
Regarding claim 2, Abe et al teaches emulsified compositions for the skin comprising petrolatum, water, etc.
Regarding the viscosity, 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 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 Takakura and Homma et al, it would have been obvious to formulate emulsions with an O/W emulsion structure, as instantly claimed.
Further, 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 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 particles at the interface between the phases, it would have been obvious to modify the emulsion of Abe et al by further including vesicles comprising an amphiphilic substance at the interphase between the oil and water phases and the functional component and the aqueous phase, where these particles were known from Horiuchi et al to result in improved stability, where both are directed to emulsions with stability as the common goal.
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 Homma et al teaches polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance at the interface between the phases 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, it would have been further obvious to modify Abe et al to include polycondensation polymers at the interface between the phases and/or vesicles as instantly claimed, for the above mentioned benefits.
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 claim 7, 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 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 and Homma 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, the limitation of a base for an external agent for skin or mucus membrane as an ointment appears to simply be the intended use of the base. Where the base made obvious above comprises the same components as instantly claimed, and can be used to formulate cosmetic and pharmaceutical compositions, it appears the base would be capable of meeting the intended use limitation. Further, it appears the form of being an ointment is an inherent characteristic of the composition made obvious above. See MPEP 2112(III).
Regarding claim 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 claim 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 claims 18 and 19, it would have been obvious to formulate the aqueous phase with known ranges taught to by suitable by Abe et al, such as between 40 and 75 wt%, thereby resulting in an oil phase that is less than 70 wt%.
Regarding claims 20 and 21, it would have been obvious to formulate the emulsion composition made obvious above comprising petrolatum in an amount of 15 to 20 wt%, as taught by Abe et al, falling within the claimed range.
Response to Arguments
Applicants argument with respect to Abe et al, Horiuchi et al, and Homma et al are discussed above.
Respectfully, these arguments are not persuasive. Applicants’ arguments appear to be directed to the newly amended limitation of claim 1, but it does not appear that any of claims 2, 5-7, 12-21, and 23-27 require the water-insoluble functional component as an additional inner phase, but rather a single oil phase, a single aqueous phase, and a water-insoluble or water-soluble functional component in the oil or aqueous phase.
Claims 1, 3, 4, 8, 9, and 22, are rejected under 35 U.S.C. 103 as being unpatentable over Sonti et al (US 20160338973 A1), in view of Takakura et al (US 20110206627 A1, hereinafter “Takakura”), 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 as a separately maintained inner phase, nor particles of a polycondensation polymer at the interface of the phases as instantly claimed.
Takakura is discussed above but do not appear to specifically teach particles of a polycondensation polymer at the interface of the phases as instantly claimed.
Abe et al are discussed above but do not appear to specifically 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), as taught by Sonti et al.
Regarding the additional inner phase of water insoluble functional component of claim 1, it would have been obvious for a skilled artisan to formulate the emulsion made obvious above by including an additional inner phase as a separate inner phase distinct from the oil phase, where Takakura teaches it was known that providing O/W emulsions with multiple inner phases, where the active agent is dispersed in one of the inner phases, results in compositions that are excellent in formulation stability, feeling in use, and UV protection ability. Further, it would have been obvious to include the additional inner phase where it was known from Takakura that when two inner phases are not present, the formulations resulted in a sticky feel. Finally, where Takukura teaches that the active agent stability was increased when included in a distinct inner phase due to poor solubility in the other, the skilled artisan would have motivation to include an additional inner phase in order to optimize the solubility of the active agent, in order to keep the active agent stable without precipitation over time.
Regarding particles at the interface between the phases, it would have been obvious to modify the emulsion further including vesicles comprising an amphiphilic substance at the interphase between the oil and water phases and the functional component and the aqueous phase, where these particles were known from Horiuchi et al to result in improved stability, where both are directed to emulsions with stability as the common goal.
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 Homma et al teaches polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance at the interface between the phases 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, it would have been further obvious to modify the combination above to include polycondensation polymers at the interface between the phases and/or vesicles as instantly claimed, for the above mentioned benefits.
Regarding the viscosity, it would have been obvious to select from known petrolatum viscosities suitable for emulsified compositions, such as semi-solid petrolatum as taught by Abe et al. 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 reasonably 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 claim 3, 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 claim 4, 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 8, 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 claim 9, 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 22, 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.
Response to Arguments
Applicants assert, as noted above, Abe et al in view of Horiuchi et al and Homma et al do not teach the claimed multiphase emulsion structure as recited in claims 1, 2, 5, 12, and 14. Applicants assert that Sonti does not remedy the deficiency of Abe et al in view of Horiuchi et al and Homma et al. Applicants assert that Sonti et al disclose a conventional two-phase O/W emulsion in which a functional component is dissolved or solubilized in either the oil phase or the aqueous phase. Applicants assert although Sonti et al describe preparing an active phase separately prior to mixing, the active is not maintained as a structurally distinct dispersed inner phase in the final emulsion and does not form its own interface with the aqueous phase.
Second, Applicants assert Sonti et al do not teach or suggest particles of a polycondensation polymer or vesicles formed of an amphiphilic substance present at an interface between phases, nor stabilizing at multiple interfaces within a single emulsion system. Applicants assert the reconstruction is based on impermissible hindsight.
First, respectfully, this argument is not persuasive. In view of Applicants amendments to claim 1, Takakura is newly cited above for motivation to include an oil phase as an inner phase and a water-insoluble functional component as an additional inner phase, for the same reasons discussed above. Applicants assert the multiphase emulsion structure with an additional inner phase is recited in claims 1, 2, 5, 12, and 14, however, it appears that only claims 1, 4, 8, 9, and 22 require this structure. Claims 2, 5, 12, and 14 recite an emulsion comprising an oil phase as an inner phase, the oil phase or aqueous phase comprising an active agent, and particles of a polycondensation polymer having a hydroxyl group and/or vesicles formed of an amphiphilic substance presence at the interface between the oil phase and the aqueous phase, but do not appear to require an additional inner phase as required by newly amended claim 1.
Second, respectfully, this argument is not persuasive. In view of Applicants amendments to claim 1, Takakura is newly cited above for motivation to include an oil phase as an inner phase and a water-insoluble functional component as an additional inner phase, for the same reasons discussed above. The examiner notes that Sonti et al were not relied upon for teaching particles of a polycondensation polymer or vesicles formed of an amphiphilic substance present at an interface between phases.
Regarding Applicants argument of hindsight, In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, the combination made obvious above would have required no more than the teachings and motivation provided by each reference, and the knowledge that was within the relative skills of the skilled artisan at the time the claimed invention was made.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Sonti et al (US 20160338973 A1), Takakura et al (US 20110206627 A1, hereinafter “Takakura”), 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, 3, 4, 8, 9, and 22 above, and further in view of Nakamura (US 20100272763 A1).
The reference are discussed above, and purely arguendo, 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 claim 22, 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.
Claims 2, 5-7, 12-21, and 23-27, 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 are discussed above but do not appear to 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 appear to 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 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, 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 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 claim 12, where Sonti et al teach the oil phase comprising petrolatum 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, as taught by Sonti et al, thereby meeting the intended use limitation.
Regarding claim 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 claim 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 claims 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 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 claims 23-27, 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.
Response to Arguments
Applicants argument with respect to Sonti et al, Abe et al, Horiuchi et al, and Homma et al are discussed above.
Respectfully, these arguments are not persuasive. Applicants’ arguments appear to be directed to the newly amended limitation of claim 1, but it does not appear that any of claims 2, 5-7, 12-21, and 23-27 require the water-insoluble functional component as an additional inner phase, but rather a single oil phase, a single aqueous phase, and a water-insoluble or water-soluble functional component in the oil or aqueous phases. Accordingly, the claims stand rejected for the same reasons above and of record.
Claims 23-27 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 2, 5-7, 12-21, and 23-27 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 23-27, 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.
Response to Arguments
Applicants do not appear to have provided arguments with respect to the combination of Sonti et al, Abe et al, Homma et al, and Nakamura et al.
Accordingly, the claims stand rejected for the same reasons above and of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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