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 . Claims included in the prosecution are claims 1, 4-6 and 8-16.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 has been entered.
Applicants' arguments, filed 12/02/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Objections
Claim 1 is objected to because of the following informalities: there should be a comma between “water” and “plate-shaped inorganic particle powder” in the second line. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 fails to further limit claim 1 since claim 1 recites 0.001 to 2 wt. % water and claim 4 recites 0.1 to 5 parts by weight with respect to 100 parts (i.e., 0.1 to 5%) water, which broadens the scope.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
1. Claims 1, 4, 6, 8, 9 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Barness et al. (US 2004/0235756, Nov. 25, 2004) (hereinafter Barness) in view of Mershon (US 2003/0008011, Jan. 9, 2003), and KR 20150015580 A (Feb. 11, 2015).
Barness discloses a protective agent suitable to protect the human skin against lesions caused by vesicants or other percutaneous chemical agents, which comprises a protective-effective amount of a hydrophilic water-based cream together with one or more additives selected from among the group consisting essentially of polyols, polysaccharides, and salts of inorganic or inorganic acids (abstract). The composition may comprise from 0% to 86% water (Table 1). Suitable additives include potassium carbonate (i.e., inorganic salt adjusting agent) (¶ [0023]). The addition of additives enhances repelling of sulfur mustard from the skin surface (¶ [0022]). While the presence of active materials is not a necessity in the protective agents, any suitable active agent can be added. Furthermore, the protective agent may further comprise reactive materials (¶ [0024]).
Barness differs from the instant claims insofar as not disclosing wherein the composition comprises plate-like inorganic particle powder.
However, Mershon discloses wherein several ointments or creams (topical skin protectants) were developed to shield skin from contamination with toxic chemical warfare agents. Some of these protectants incorporated camouflage pigments (¶ [0006]).
KR 20150015580 A discloses wherein plate-like pigment, mica is surface treated with magnesium hydroxide to have a soft focus effect (abstract). A soft focus effect is an aesthetic effect obtained by clouding the surface of the object (page 3).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated plate-like mica surface treated with magnesium hydroxide into the composition of Barness since skin protectant compositions comprise pigments as taught by Mershon and plate-like mica surface treated with magnesium hydroxide is a known and effective pigment as taught by KR 20150015580 A.
In regards to instant claim 1 reciting wherein the plate-shaped inorganic particle powder is included at 0.5 to 30 wt. %, since plate-like mica is a pigment, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount of plate-like mica depending on the level of pigmentation desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See 2144.05(II)(A).
In regards to instant claim 8 reciting how the plate-shaped inorganic particle powder is surface treated, this is a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113. Therefore, since a surface-treated plate-like inorganic particle is obvious from the prior art disclosing plate-like mica surface-treated with magnesium hydroxide, claim 8 is unpatentable even though the plate-like mica of the prior art was surface-treated using a different process.
In regards to instant claim 9 reciting wherein the inorganic substance is included at 0.5 to 20 parts by weight, since KR 20150015580 A discloses wherein surface-treating with magnesium hydroxide is what causes the soft focus effect, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount depending on the level of soft focus desired.
2. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Barness et al. (US 2004/0235756, Nov. 25, 2004) (hereinafter Barness) in view of Mershon (US 2003/0008011, Jan. 9, 2003), KR 20150015580 A (Feb. 11, 2015), and further in view of Ballesteros et al. (US 2014/0271738, Sep. 18, 2014) (hereinafter Ballesteros).
The teachings of Barness, Mershon, and KR 20150015580 A are discussed above. Barness, Mershon, and KR 20150015580 A do not teach the particle size of the plate-like mica.
However, Ballesteros discloses a pigmented skin care composition comprising interference pigments (abstract). Interference pigments are typically thin plate-like particles including two or more layers. Suitable interference pigments include mica coated with thin films of TiO2 or Fe2O3 (¶ [0014]). Interference pigments have a particle size range wherein fifty percent of the particles fall within the size range (D50) of about 2 µm and about 75 µm (¶ [0015]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the plate-like mica to have a particle size ranging from about 2 µm and about 75 µm since this is a known and effect particle size for pigments used in skin care compositions as taught by Ballesteros.
3. Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Barness et al. (US 2004/0235756, Nov. 25, 2004) (hereinafter Barness) in view of Mershon (US 2003/0008011, Jan. 9, 2003), KR 20150015580 A (Feb. 11, 2015), and further in view of Chilcott et al. (GB 2314020 A, Dec. 17, 1997) (hereinafter Chilcott), Avalle (US 6,004,541, Dec. 21, 1999) and Silibase (Silibase-9806 Dimethicone, Mar. 7, 2020).
The teachings of Barness, Mershon, and KR 20150015580 A are discussed above. Barness, Mershon, and KR 20150015580 A do not teach wherein the composition comprises liquid perfluoride.
However, Chilcott discloses a topical barrier composition which hinder or prevent passage of e.g. chemical warfare agent into the skin by containing a perfluorinated polymeric compound (abstract). Such compounds have low surface energy and thereby prevent portioning of volatile chemical into the topical composition and skin (page 2, lines 21-22). The perfluorinated polymeric compound is an oil (claim 2).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Barness discloses wherein the composition may comprise active agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated perfluorinated polymeric compound in oil form into the composition since perfluorinated polymeric compounds are known and effective active agents for hindering or preventing passage of chemical warfare agents into the skin as taught by Chilcott.
The combined teachings of Barness, Mershon, KR 20150015580 A, and Chilcott do not teach wherein the composition comprises perfluorinated polymer powder.
However, Avalle discloses perfluoridated-derivatives covered powder for products which boasts protection against sunbeams or UV rays (col. 1, lines 7-9).
Barness discloses wherein the composition may comprise active agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated perfluoridated-derivatives covered powder into the composition since perfluoridated-derivatives covered powder are known and effective active agents for protection against sunbeams or UV rays as taught by Avalle.
Barness, Mershon, KR 20150015580 A, Chilcott, and Avalle do not disclose wherein the composition comprises a liquid silicon-based material/silicon-based film-forming agent.
However, Silibase discloses a dimethicone with the following molecular formula:
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.
The compound has excellent spreading ability, enhances smoothness, and functions as a lubricating agent.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Barness discloses wherein the composition may comprise active agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated the dimethicone of Silibase into the composition since the dimethicone is a known and effective active agent for functioning as an excellent spreading agent (i.e., film-forming), enhancing smoothness, and lubricating agent as taught by Silibase.
In regards to the n value recited in claim 13, Silibase does not disclose what the n value is; however, it would have taken no more than the relative skills in the art through routine experimentation to have arrived at the claimed n value based on arriving at a compound that is effective as a spreading agent, smoothening agent, and lubricating agent.
In regards to the amount of silicon-based film-forming agent recited in instant claim 10, since the dimethicone of Silibase is a known and effective active agent for spreading, smoothening, and lubricating, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount depending on the level of spreading, smoothening, and lubircating desired.
In regards to the amount of liquid perfluoride recited, since perfluorinated polymeric compound in oil form are known and effective active agents for hindering or preventing passage of chemical warfare agents into the skin, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount depending on the level of additional protection from chemical warfare agents desired.
In regards to the amount of perfluorinated polymer powder recited, since perfluoridated-derivatives covered powder are known and effective active agents for protection against sunbeams or UV rays, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount depending on the level of protection against sunbeams and UV rays desired.
In regards to the amount of polyol and polysaccharide recited, since the additives of Barness are provided to enhance the protective effect, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amounts depending on the level of enhancement desired.
4. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Barness et al. (US 2004/0235756, Nov. 25, 2004) (hereinafter Barness) in view of Mershon (US 2003/0008011, Jan. 9, 2003), KR 20150015580 A (Feb. 11, 2015), and further in view of Chilcott et al. (GB 2314020 A, Dec. 17, 1997) (hereinafter Chilcott) and Trusiano et al. (Novel perfluoropolyalkylethers monomers: synthesis and photo-induced cationic polymerization, Apr. 25, 2021) (hereinafter Trusiano).
The teachings of Barness, Mershon, and KR 20150015580 A are discussed above. Barness, Mershon, and KR 20150015580 A do not teach wherein the composition comprises liquid perfluoride.
However, Chilcott discloses a topical barrier composition which hinder or prevent passage of e.g. chemical warfare agent into the skin by containing a perfluorinated polymeric compound (abstract). Such compounds have low surface energy and thereby prevent portioning of volatile chemical into the topical composition and skin (page 2, lines 21-22). The perfluorinated polymeric compound is an oil (claim 2).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Barness discloses wherein the composition may comprise active agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated perfluorinated polymeric compound in oil form into the composition since perfluorinated polymeric compounds are known and effective active agents for hindering or preventing passage of chemical warfare agents into the skin as taught by Chilcott.
The combined teachings of Barness. Mershon, KR 20150015580 A do not teach wherein the composition comprises the liquid perfluoride of claim 11.
However, Trusiano discloses
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(Page 1180, Scheme 3).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As discussed above, it would have been obvious to have incorporated a perfluorinated polymeric compound into the composition of Barness as taught by Chilcott. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated PFPAE acryl fluoride into the composition since PFPAE acyl fluoride is a known perfluorinated polymeric compound as taught by Trusiano.
In regards to the n value recited in claim 11, Trusiano does not disclose what the n value is; however, it would have taken no more than the relative skills in the art through routine experimentation to have arrived at the claimed n value based on arriving at a polymeric compound that is effective in hindering or preventing passage of chemical warfare agents into the skin.
5. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Barness et al. (US 2004/0235756, Nov. 25, 2004) (hereinafter Barness) in view of Mershon (US 2003/0008011, Jan. 9, 2003), KR 20150015580 A (Feb. 11, 2015), and further in view of Avalle (US 6,004,541, Dec. 21, 1999) and McCreery (US 5,607,979, Mar. 4, 1997).
The teachings of Barness, Mershon, and KR 20150015580 A are discussed above. Barness, Mershon, and KR 20150015580 A do not teach wherein the composition comprises perfluorinated polymer powder.
However, Avalle discloses perfluoridated-derivatives covered powder for products which boasts protection against sunbeams or UV rays (col. 1, lines 7-9).
Barness discloses wherein the composition may comprise active agents. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated perfluoridated-derivatives covered powder into the composition since perfluoridated-derivatives covered powder are known and effective active agents for protection against sunbeams or UV rays as taught by Avalle.
The combined teachings of Barness. Mershon, KR 20150015580 A do not teach wherein the perfluoridated-derivatives covered powder has an average particle diameter of 1 to 10 µm and a specific surface area of 3 to 15 m2/g.
However, McCreery discloses suspensions of finely divided PTFE in a perfluorinated polyether base oil (col. 4, lines 18-19). The finely divided PTFE has an average particle size below about 5 µm and a surface area below about 4 m2/g (col. 4, lines 43-44). The composition may be in the form of a cream and affords good protection against chemical warfare agents (abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the perfluoridated-derivatives covered powder to have an average particle size below about 5 µm and a surface area below about 4 m2/g since these are known and effective properties for particles used in skin care compositions for protecting skin against chemical warfare agents as taught by McCreery.
Response to Arguments
Applicant argues that the amount of plate-shaped inorganic particle powder specified in the present claims is not derivable through routine experimentation because it is a technical feature that directly affects detoxification efficiency through the control of reaction-site density and hydroxyl-group availability.
The Examiner does not find Applicant’s argument to be persuasive. Applicant may rebut a prima facie case of obviousness based on optimization of a variable disclosed in a range in the prior art by showing that the claimed variable was not recognized in the prior art to be a result-effective variable. See MPEP 2144.05(III)(A). The MPEP does not state wherein the result-effect has to be the same as Applicant’s. Therefore, it is not necessary for the prior art to optimize to the claimed range for the same reason as Applicant. Since Applicant has not shown wherein the claimed amounts are not result-effective variables as described in the rejection, Applicant’s argument is unpersuasive.
Moreover, although Applicant argues that if the inorganic particle powder content is less than 0.5 wt. %, the increase in surface area and detoxification effect is negligible, while amounts above 30 wt. % undesirably increase viscosity, these are conclusory statement from the instant specification. Mere conclusory statements in the specification, unsupported by objective evidence, are entitled to little weight when the PTO questions the efficacy of those statements. In re Greenfield, 571 F.2d 1185, 197 U.S.P.Q. 227, 229 (C.C.P.A. 1978). As such, Applicant’s argument is further unpersuasive.
Applicant argues that the camouflage pigment of Mershon cannot be regards as corresponding to the plate-type pigments disclosed in KR 2015015580.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not say that. The rejection states that since skin protectant compositions comprise pigments as taught by Mershon and plate-like mica surface treated with magnesium hydroxide is a known and effective pigment as taught by KR 20150015580 A, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated plate-like mica surface treated with magnesium hydroxide into the composition of Barness. As such, Applicant’s argument is unpersuasive.
Applicant argues that even if the surface-treatment method of KR 2015015580 A were applied to the camouflage pigment used in the moist biological environment of Mershon, there is no basis to conclude that the resulting product would correspond to the surface-treated inorganic particle powder of the present invention.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state wherein the surface-treatment method of KR 2015015580 A would be applied to the camouflage pigment of Mershon. Therefore, Applicant’s argument is unpersuasive.
Applicant argues that the skin-protection composition of the present invention not only provides physical protection but also achieves a chemical detoxification effect due to the inclusion of the plate-shaped inorganic particle powder surface treated with a different inorganic substance recited in the Markush group. This unexpected effect is demonstrated in Experimental Example 2 of the present invention.
The Examiner does not find Applicant’s argument to be persuasive. The claimed plate-shaped inorganic particle powder surface-treated with a different inorganic substance is known in the art. As discussed in the rejection, KR 20150015580 A discloses plate-like pigment mica surface treated with magnesium hydroxide. Applicant discovering that such particle has physical protection and chemical detoxification effect does not make the claimed patentable. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See MPEP 2112(I). As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 4-6 and 8-16 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614