DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 21-37, and 41 are pending and represent all claims currently under consideration.
Claim 41 is withdrawn.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/04/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks (pages 8-10), filed 03/04/2026, with respect to the rejection(s) of claim(s) 1, 21-37, and 39-40 under U.S.C. 103 have been fully considered and are persuasive due to the amendment. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nagamatsu, Harada, and Mason.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claims 1 and 21-37 are considered to have an effective filing date of 03/04/2021.
Information Disclosure Statement
The information disclosure statement filed 07/09/2026 has been considered.
New 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.
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.
Claims 1 and 21-35 are rejected under 35 U.S.C. 103 as being unpatentable over Nagamatsu (US 9913782 B2), further in view of Harada (US 20180243197 A1), and as evidenced by Ikeda (US 11260000 B2).
Regarding claim 1, Nagamatsu teaches a composition which is preferably in the form of an oil-in-water emulsion (i.e., comprises an aqueous phase and an oil phase; Nagamatsu, column 24, lines 36-39). Nagamatsu exemplifies a composition comprising propylene glycol (i.e., a dihydric glycol) in the aqueous phase in 4% by weight, and an oil phase in 45.3% by weight (Nagamatsu, columns 27-28, example 3). Nagamatsu teaches glycerol in 2% by weight (Nagamatsu, columns 27-28, example 3), and teaches ethanol (i.e., a monohydric alcohol) and glycerol as alternative embodiments (Nagamatsu, column 22, lines 19-21). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to utilize ethanol in the same amount, which lies within the claimed range. Nagamatsu teaches composite particles which can be oval shaped (Nagamatsu, column 6, lines 16-30) and lamellar (i.e., oval-shaped lamellar nanodiscs; Nagamatsu, column 10, lines 14-15), and teaches a large (i.e., major) axis of less than 10 micrometers (Nagamatsu, column 6, lines 40-42), which encompasses the claimed range. 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). As evidenced by Ikeda, a lamellar structure or phase is defined as being present at the interface between the oil and water phases (Ikeda, columns 40-41). Therefore, it would be reasonable to expect the lamellar particles of Nagamatsu would be absorbed at the oil-water interface as claimed.
While Nagamatsu does not specifically teach a polyoxyalkylene-modified silicone (C) or an ionic surfactant (D) from the claimed list, Nagamatsu teaches the composition comprises emulsifying silicone surfactants (Nagamatsu, column 24, lines 45-60) and ionic surfactants (Nagamatsu, column 22, lines 35-41).
Harada teaches a composition in the form of an oil-in-water emulsion (Harada, claim 1), and teaches a polyether modified silicone which has polyoxyalkylene groups (i.e., a polyoxyalkylene-modified silicone (C)) is present in a content ranging from about 0.01-10% by weight of the composition (Harada, claim 5), which encompasses the claimed range. Harada exemplifies a composition comprising sodium methyl stearoyl taurate (i.e., an N-stearoyl-N-methyltaurine salt, which is an ionic surfactant (D) as defined by the instant claim 21) in 0.2% by weight (Harada, page 8, table 3), which would result in a possible content ratio of (C) to (D) of 1:0.02 to 1:20, which encompasses the claimed range.
Nagamatsu and Harada are considered to be analogous to the claimed invention, because Nagamatsu, Harada, and the instant invention are in the same field of cosmetic oil-in-water emulsions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Nagamatsu to include the surfactants taught by Harada, because Nagamatsu teaches the composition comprises emulsifying silicone surfactants (Nagamatsu, column 24, lines 45-60) and ionic surfactants (Nagamatsu, column 22, lines 35-41), while Harada teaches the specific surfactants as claimed and teaches such surfactants for improving skin affinity and inhomogenous spreading in O/W emulsions (Harada, page 1, paragraphs 0004-0005).
Regarding claim 21, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 1. As above, Harada teaches the composition comprises sodium methyl stearoyl taurate (i.e., an N-stearoyl-N-methyltaurine salt; Harada, page 8, table 3).
Regarding claim 22, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 1. As above, Harada teaches the composition comprises sodium methyl stearoyl taurate (i.e., an N-stearoyl-N-methyltaurine salt, which is an ionic surfactant (D) as defined by the instant claim 21) in 0.2% by weight (Harada, page 8, table 3), which lies within the claimed range.
Regarding claim 23, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 1. Nagamatsu teaches a composition comprising 1% by weight of dextrin palmitate (i.e., a polymer; Nagamatsu, column 28, example 6). As evidenced by Harada, dextrin palmitate is defined as a thickener (Harada, page 6, paragraph 0105).
Regarding claim 24, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 23. Nagamatsu teaches carboxyvinyl polymers as thickeners (Nagamatsu, column 22, lines 51-52).
Regarding claim 25, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 23. Nagamatsu teaches polyacrylamides (i.e., acrylic polymers) as thickeners (Nagamatsu, column 22, lines 51-56).
Regarding claim 26, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 25. As above, Nagamatsu teaches polyacrylamides (i.e., acrylic polymers) as thickeners (Nagamatsu, column 22, lines 51-56), but does not specify a polyacrylamide from the claimed list. Harada, however, teaches the use of ammonium acryloyldimethyltaurate/vp copolymer (i.e., a thickener from the claimed list; Harada, page 6, paragraph 105). It would have been prima facie obvious for one of ordinary skill in the art to utilize the specific polymer taught by Harada in the composition of Nagamatsu, because Nagamatsu teaches the use polyacrylamides (i.e., acrylic polymers) as thickeners (Nagamatsu, column 22, lines 51-56) and of organic UV-screening agents (Nagamatsu, column 11, lines 60-62), while Harada teaches a polyacrylamide used for boosting sun protection of UV filters (Harada, page 6, paragraphs 0101-0105).
Regarding claim 27, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 1. Nagamatsu teaches a photoprotective agent, such as polyorganosiloxane (i.e., a silicone elastomer as defined by the instant specification, page 10, paragraph 0032; Nagamatsu, column 14, line 39).
Regarding claim 28, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 1. Nagamatsu teaches the composition can comprise ethanol (i.e., ethyl alcohol; Nagamatsu, column 22, lines 19-21).
Regarding claim 29, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 1. Nagamatsu teaches the composition can comprise dipropylene glycol (Nagamatsu, column 22, line 15).
Regarding claim 30, Nagamatsu teaches a composition which is preferably in the form of an oil-in-water emulsion (i.e., comprises an aqueous phase and an oil phase; Nagamatsu, column 24, lines 36-39). Nagamatsu exemplifies a composition comprising propylene glycol (i.e., a dihydric glycol) in the aqueous phase in 4% by weight, and an oil phase in 45.3% by weight (Nagamatsu, columns 27-28, example 3). Nagamatsu teaches glycerol in 2% by weight (Nagamatsu, columns 27-28, example 3), and teaches ethanol (i.e., a monohydric alcohol) and glycerol as alternative embodiments (Nagamatsu, column 22, lines 19-21). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to utilize ethanol in the same amount, which lies within the claimed range. Nagamatsu teaches composite particles which can be oval shaped (Nagamatsu, column 6, lines 16-30) and lamellar (i.e., oval-shaped lamellar nanodiscs; Nagamatsu, column 10, lines 14-15), and teaches a large (i.e., major) axis of less than 10 micrometers (Nagamatsu, column 6, lines 40-42), which encompasses the claimed range. 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). As evidenced by Ikeda, a lamellar structure or phase is defined as being present at the interface between the oil and water phases (Ikeda, columns 40-41). Therefore, it would be reasonable to expect the lamellar particles of Nagamatsu would be absorbed at the oil-water interface as claimed.
While Nagamatsu does not specifically teach a polyoxyalkylene-modified silicone (C), Nagamatsu teaches the composition comprises emulsifying silicone surfactants (Nagamatsu, column 24, lines 45-60) and ionic surfactants (Nagamatsu, column 22, lines 35-41).
Harada teaches a composition in the form of an oil-in-water emulsion (Harada, claim 1), and teaches a polyether modified silicone which has polyoxyalkylene groups (i.e., a polyoxyalkylene-modified silicone (C)) is present in a content ranging from about 0.01-10% by weight of the composition (Harada, claim 5), which encompasses the claimed range. Harada exemplifies a composition comprising sodium methyl stearoyl taurate (i.e., an N-stearoyl-N-methyltaurine salt, which is an ionic surfactant (D) as defined by the instant claim 21) in 0.2% by weight (Harada, page 8, table 3), which would result in a possible content ratio of (C) to (D) of 1:0.02 to 1:20, which encompasses the claimed range. As above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Nagamatsu to include the surfactants taught by Harada, because Nagamatsu teaches the composition comprises emulsifying silicone surfactants (Nagamatsu, column 24, lines 45-60) and ionic surfactants (Nagamatsu, column 22, lines 35-41), while Harada teaches the specific surfactants as claimed and teaches such surfactants for improving skin affinity and inhomogenous spreading in O/W emulsions (Harada, page 1, paragraphs 0004-0005).
Regarding claim 31, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 30. As above, Harada teaches a composition in the form of an oil-in-water emulsion (Harada, claim 1), and teaches a polyether modified silicone which has polyoxyalkylene groups (i.e., a polyoxyalkylene-modified silicone (C)) is present in a content ranging from about 0.01-10% by weight of the composition (Harada, claim 5), which encompasses the claimed range. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Nagamatsu to include the surfactant taught by Harada, because Nagamatsu teaches the composition comprises emulsifying silicone surfactants (Nagamatsu, column 24, lines 45-60), while Harada teaches the specific surfactants as claimed and teaches such surfactants for improving skin affinity and inhomogenous spreading in O/W emulsions (Harada, page 1, paragraphs 0004-0005).
Regarding claim 32, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 31. Nagamatsu teaches the oil phase can comprise silicone oils (Nagamatsu, column 18, lines 64-67), such as cyclic silicone oils containing from 2 to 7 silicone atoms (Nagamatsu, column 21, lines 7-11), and exemplifies a composition comprising an oily phase C comprising 2% by a weight of the total composition of a mixture of cyclopentasiloxane (i.e., a cyclic silicone oil), disteardimonium hectorite, and denatured alcohol, and 4.5% by weight of isododecane (Nagamatsu, columns 27-28, example 3), which results in an amount of less than about 30.7% by weight of cyclopentasiloxane, which lies within the claimed range.
Regarding claim 33, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 31. While Nagamatsu does not specifically teach a PEG-12 dimethicone, Nagamatsu teaches the composition comprises emulsifying silicone surfactants (Nagamatsu, column 24, lines 45-60). Harada teaches modified silicones such as PEG-12 dimethicone (Harada, page 3, paragraph 0049). As above, it would have been prima facie obvious to one of ordinary skill in the art to use a surfactant as taught by Harada, because Harada teaches the specific surfactants as claimed and teaches such surfactants for improving skin affinity and inhomogenous spreading in O/W emulsions (Harada, page 1, paragraphs 0004-0005).
Regarding claim 34, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 33. As above, Harada teaches a polyether modified silicone which has polyoxyalkylene groups (i.e., a polyoxyalkylene-modified silicone (C)) is present in a content ranging from about 0.01-10% by weight of the composition (Harada, claim 5), which overlaps the claimed range. 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). Harada teaches modified silicones such as PEG-12 dimethicone (Harada, page 3, paragraph 0049). The phrase “that does not dissolve but precipitates in water” is considered to be a property of the claimed amount of PEG-12 dimethicone. A chemical composition and its properties are inseparable. See MPEP § 2112.01(II). Therefore, it would be reasonable to expect the amount of PEG-12 dimethicone taught by Harada would not dissolve but precipitates in water as claimed. It would have been prima facie obvious to one of ordinary skill in the art to use a surfactant in the amount as taught by Harada, because Harada teaches the specific surfactants as claimed and teaches such surfactants for improving skin affinity and inhomogenous spreading in O/W emulsions (Harada, page 1, paragraphs 0004-0005).
Regarding claim 35, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 33. Harada teaches a silicone which is commercially available as SH3775M (Harada, page 3, paragraph 0050), which is PEG-12 dimethicone with an HLB of 5 as defined by the instant specification (pages 13-14; table 2). As above, it would have been prima facie obvious to one of ordinary skill in the art to use a surfactant as taught by Harada, because Harada teaches the specific surfactants as claimed and teaches such surfactants for improving skin affinity and inhomogenous spreading in O/W emulsions (Harada, page 1, paragraphs 0004-0005). Regarding Griffin’s formula, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Nagamatsu (US 9913782 B2) and Harada (US 20180243197 A1) as applied to claims 1 and 21-35, further in view of Mason (WO 2009025802 A1), and as evidenced by West Lab. Mason and West Lab were cited previously by the Examiner.
Regarding claim 36, Nagamatsu and Harada together teach all the elements of the current invention as applied to claim 30. Nagamatsu and Harada do not teach centrifugation or separation of the emulsion into layers. Mason, however, teaches oil-in-water emulsions (Mason, page 17, paragraph 0038) which can be a cosmetic (Mason, page 18, paragraph 0039) wherein the emulsion comprises silicone oils and water (Mason, page 13, paragraph 0027) and which possess the ability to aggregate into nanostructure vesicles (Mason, page 5, paragraph 0010). Mason teaches the vesicles are composed of lamellar membranes which form a film at the oil-water interface (Mason, page 30, paragraph 0057). Mason further teaches droplet (i.e., particle) size is affected by centrifugation speed/time and teaches a droplet size after centrifugation of 30-200 nm (Mason, page 29, paragraph 0055), which overlaps the claimed range of 30-150 nm. Mason does not specifically teach centrifugation at 40,000 rpm for 60 minutes, but a measurement in rpm is dependent on the individual centrifuge being used, as evidenced by West Lab. One of ordinary skill in the art would know that rpm is dependent on the centrifuge, and would know to optimize the speed to achieve the optimal droplet size as taught by Mason. Mason further demonstrates the emulsion as a clear layer separated from a lower layer (Mason, figure 6E).
Nagamatsu, Harada, and Mason are considered to be analogous to the claimed invention, because all are in the same field of cosmetic emulsion compositions. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teaching of Nagamatsu and Harada to include a centrifugation step, because Mason teaches droplet (i.e., particle) size is affected by centrifugation speed/time (Mason, page 29, paragraph 0055) and that control of the droplet size is important for drug delivery applications (Mason, page 28, paragraph 0054). Nagamatsu teaches the composition may be prepared according to techniques known in the art, and states that with certain methods it is possible to obtain stable dispersions with drop sizes as low as 100 nm (Nagamatsu, column 24, lines 4-30), suggesting this as a desirable outcome.
Regarding claim 37, Nagamatsu, Harada, and Mason together teach all the elements of the current invention as applied to claim 30. As above, Mason teaches droplet (i.e., particle) size is affected by centrifugation speed/time (Mason, page 29, paragraph 0055). Mason teaches a centrifugation at 3,500 rpm over 4 hours had to be followed by a higher speed centrifuge in order to separate droplets with diameters of 30-200 nm (Mason, page 29, paragraph 0055), which overlaps the claimed range of 30-150 nm, and to stabilize the droplet interface (i.e., emulsion layers; Mason, page 29, paragraph 0055), which suggests the layers would not be clearly separated if a lower speed of 3,000 rpm as claimed is used (i.e., no clear separated layer of oil in either an upper or lower level). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have centrifuged the composition of Nagamatsu and Harada to attain a desired droplet size by centrifuging at high speeds as taught by Mason, because Mason teaches control of the droplet size is important for drug delivery applications (Mason, page 28, paragraph 0054).
Conclusion
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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