DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Claim Rejections - 35 USC § 103 - withdrawn
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 rejection of Claim(s) 39-41,44,46,127 under 35 U.S.C. 103 as being unpatentable over Holme et al. (US 6685916; 02/03/2004) is withdrawn. Independent claim 39 has been amended to recite/require “ wherein each of the one or more first compounds comprises a monoacylglyceride” and “from about 0.1% to about 35% by mass of one or more wetting agents selected from the group consisting of fatty acids, fatty acid esters, and fatty acid salts, wherein each of the one or more wetting agents has a carbon chain length in a range of 7 to 13 “ which are two added limitations not taught by the prior art. Therefore the rejection over Holme et al. on record is withdrawn.
The rejection of Claim(s) 39-41,44,46,127 under 35 U.S.C. 103 as being unpatentable over Masubuchi et al. (JP 20042107041A; 12/27/2002) is withdrawn.
The withdrawn over Masubuchi et al. of record is “Masubuchi et al. at paragraph 7 teach a skin cleaning composition comprising a higher fatty salt(anionic surfactant). Paragraph 7 also teach the inclusion of fats making include tallow, coconut, soybean , oleic acid, capric acid, lauric, myristic, palmitic, stearic and the cation contributing to the salt are sodium, potassium, monoethanol amine. Masubuchi et al. at paragraph 8 teach that the 5-30% of fatty acid salt is present in the skin cleaning composition. Masubuchi paragraph 14 teach the inclusion of lauryl alcohol(fatty alcohol derivative) in the cleaning composition. Masubuchi et al. at paragraph 18 teach inclusion of surfactants(wetting agents) such as phospholipids, amphoteric, cationic surfactants and fatty acid alkylolamides in the cleaning composition. Masubuchi et al. at paragraph 31 teach inclusion of 0.5% hydrogenated phospholipid in the cleaning composition. Masubuchi et al. do not explicitly teach a single skin clean composition comprising a 5-30% higher fatty salt(anionic surfactant) plus said fats and/or salts thereof plus lauryl alcohol(fatty alcohol derivative) plus surfactants(wetting agents) such as phospholipids plus amphoteric, cationic surfactants and fatty acid alkylolamides. It would have been obvious to arrive at this single composition since Masubuchi et al. suggest that combining the ingredients would lead to a single skin cleaning composition. “
The rejection of Claims 39-41,44,46,127 is/are rejected under 35 U.S.C. 103 as being obvious over Perez et al(US 10266708; 04/23/2019)is maintained. Claim 39 has been amended to recite a composition comprising fatty acid and also monoglyceride which has been addressed in the office action. The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Perez et al. column 17 lines 28-55 teach:
“(66) However, for coatings formed from solid mixtures which contained both a compound of Formula I and an additive, where the mass or molar ratio of the additive to the compound of Formula I was in a range of 0.1 to 1, a substantial reduction in mass loss over time (e.g., as compared to uncoated edible substrates, a reduction in the mass loss rate of at least 20-30% for strawberries, finger limes, and avocados, and at least 10-20% for blueberries) was observed for the coated edible substrates, and visible precipitates and/or other visible residues or features were not observed or were substantially suppressed. This result was observed for a wide variety of additives combined with a compound of Formula I, including all of the combinations listed in Table 1, as well as for a variety of different edible substrates, including blueberries, bananas, strawberries, lemons, avocados, and limes. The reduction in mass loss over time for substrates having coatings with this specific range of mass ratios of the additives to the compounds of Formula I, accompanied by the absence of visible precipitates/residues, was unexpected, in particular since coatings formed from one of the compounds but not the other either did not produce such a large reduction in mass loss in the coated substrates over time or also resulted in heavy visible precipitates and/or other visible residues or features on the surfaces of the substrates. Further details of the compounds, the solutions, the coatings, the procedures for forming the coatings, and the results are presented in the Figures and their associated descriptions below.
(67) As described above, it was observed that for the solid mixtures which were a substantially pure compound of Formula I (e.g., at least 90% pure, at least 95% pure, or at least 99% pure), or contained the compound of Formula I but at most only small amounts of the additive (e.g., the mass or molar ratio of the additive to the compound of Formula I was less than 0.1 or 0.2 or 0.25, or the solid mixture was a substantially pure mixture of the compound of Formula I), the protective coatings that were subsequently formed all tended to at least partially precipitate or leave a visible residue on the surface of the substrate. As seen in FIG. 1, the residues were easily visible to the naked eye, creating the general appearance of a white, film-like substance over portions of the edible substrate, the portions each tending to be at least 0.25 μm.sup.2 in area, and in some cases at least 1 μm.sup.2 in area, at least 5 μm.sup.2 in area, at least 10 μm.sup.2 in area, at least 100 μm.sup.2 in area, or at least 1000 μm.sup.2 in area.”
Perez et al. claim 1 teach a composition comprising the compound of I and the compound of formula II:
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USPN ‘704 column 18 lines 38-45 teach “Combining the compounds of Formula I with a smaller concentration of additives (e.g., 1-monoacylglyceride, fatty acid, and/or ester compounds) in the solid mixtures prevented the visible residues from forming during subsequent formation of the coatings”.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claim Rejections - 35 USC § 103 - maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 39-41,44,46,127 under 35 U.S.C. 103 as being unpatentable over Fukukura et al. (JP 2519455 B2, hereinafter Fukukura) is maintained. Fukukura et al. teach a composition comprising the instant amounts of monoacylglyceride, 0.1 – 35% said fatty component plus 0.1 to 25% fatty acid salt.
An English language machine translation of Fukukura was provided with a previous correspondence in US Application Number 16/427219.
The Examiner maintains that Fukukura teaches an emulsion composition comprising, as solids/compounds in the emulsion, (A) a bile acid and/or its salt, (B) a sterol, (C) a higher fatty acid and/or its salt, and (D) a glycerin monofatty acid ester (abstract) which is equivalent to the component “monoacylglyceride”. The reference’s component (D) reads on the claimed first group of one or more compounds of Formula I, including all the R -glyceryl, R1 to R13 groups, and m, n, q, and r subscript integers (see the exemplary compounds on page 3 lines 81-91, which includes glyceryl monomyristate(a monoacylglyceride), glyceryl monostearate (a monoacylglyceride), glyceryl monooleate(a monoacylglyceride), glyceryl monoisostearate(a monoacylglyceride), glyceryl monopalmitate(a monoacylglyceride), and glyceryl monopalmitooleate(a monoacylglyceride). The reference’s component (C), specifically salt(s) of a fatty acid, reads on the claimed second group of one or more salt compounds of Formula II, including all the R1 to R13 groups, m, n, q, and r subscript integers, and X cationic moiety (see the exemplary compounds on page 2 lines 59-75 of the machine translation, which includes and/or encompass sodium and potassium salts of lauric acid, myristic acid, palmitic acid, margaric acid, and stearic acid).
It is noted the reference discloses the component (C) is a “higher fatty acid and/or its salt”. In the event some picking and choosing of the component (C) is required (e.g., the presence of the fatty acid salt rather than 1) the fatty acid itself or 2) the fatty acid in combination with a fatty acid salt), at the time of the effective filing date it would have nevertheless been obvious to a an Artisan in the field to provide the fatty acid salt by itself from the reference’s recitation of the conjunction “and/or” indicating the fatty acid salt present merely by itself is an express embodiment within the reference.
As to the claimed limitation(s) that the composition comprises 50-99.9 wt.% of the first compound(s) and 0.1-35 wt.% of the second compound(s), these limitation(s) are interpreted as broadly limiting the recited composition to include at least the two components in amounts relative to one another or in the solid-components in the composition, i.e., as an intermediate not including any additional solvent and/or liquid phase. It is noted the original specification indicates the compositions of the present invention function as emulsifiers that allow for the composition to be further dissolved, suspended, or dispersed in a solvent (e.g., paragraphs [0007] and [0047]). A composition of compounds/components containing the recited relative amounts of the first group and second group of compounds reads on the claim regardless of the presence of any additional solvent/liquid phase. Fukukura teaches the components (B), (C), and (D) are blended in respective weight ratios of 0.1-3 : 0.01-3 : 0.1-3 relative to 1 part of component (A) in order to obtain a satisfactorily emulsified composition (abstract and page 3 line 99-103 of the machine translation), which constitutes prima facie overlap of the claimed ranges of the first and second groups of compounds. Since there can be up to 3 parts by weight of the reference’s glycerin monofatty acid ester component (D) with 1 part by weight of component (A) and as little as 0.1 parts by weight component (B) and 0.01 parts by weight component (C), there can up to 73 wt.% of glycerin monofatty acid ester(s) in the composition (3 ÷ (1 + 0.1 + 0.01 + 3)), which overlaps the claimed range of the compound(s) of Formula I.
Fukukura teaches each compound of the first group of compounds has a carbon chain length of at least 14 (glyceryl monomyristate and glyceryl monostearate, which contain a C14 chain and C16 chain, respectively, are exemplary compounds for component (D) in the reference, page 3 lines 81-91).
Fukukura teaches each compound of the second group of compounds has a carbon chain length of at least 14 (a sodium or potassium salt of myristic acid or stearic acid, which contain a C14 chain and C16 chain, respectively, are exemplary compounds for component (C) in the reference, page 2 lines 59-75).
Fukukura teaches the second group of compounds comprise SA-Na, PA-Na, MA-Na, SA-K, PA-K, or MA-K (a sodium, i.e., Na, or potassium, i.e., K, salt of stearic acid, i.e., SA, palmitic acid, i.e., PA, or myristic acid, i.e., MA, are exemplary compounds for component (C) in the reference, page 2 lines 59-75).
The reference teaches a “glycerin monofatty acid ester” as sufficient for the component (D), which reads on the claimed composition comprising less than 10% by mass of diglycerides or triglycerides. The reference is silent to the presence of any triglyceride, which further reads on the claimed composition comprising less than 10% by mass of triglycerides. It is noted the reference’s abstract indicates component (D) is a glycerin monofatty acid ester “and/or” a glycerin difatty acid ester. However, in the event some picking and choosing of the component (D) is required (e.g., the presence of the glycerin monofatty acid ester, i.e., monoglyceride, rather than 1) a glycerin difatty acid ester, i.e., diglyceride, or 2) a glycerin monofatty acid ester in combination with a glycerin difatty acid ester, i.e., combination of monoglyceride and diglyceride) at the time of the effective filing date it would have nevertheless been obvious to a person of ordinary skill in the art to provide the monoglyceride/glycerin monofatty acid ester by itself free of any diglyceride/glycerin difatty acid ester from the from the reference’s recitation of the conjunction “and/or” indicating the monoglyceride/glycerin monofatty acid ester present merely by itself is an express embodiment within the reference.
Fukukura teaches an oil-in-water emulsion composition comprising, as solids/compounds in the emulsion, (A) a bile acid and/or its salt, (B) a sterol, (C) a higher fatty acid and/or its salt, and (D) a glycerin monofatty acid ester (abstract, the Problems to be Solved by the Invention section on page 1, and page 3 lines 99-104). The reference’s components (A) to (D) read on the claimed composition, and the further combination of components (A) to (D) in oil and water read on the claimed mixture comprising a composition in a solvent. The reference’s component (D) reads on the claimed first group of one or more compounds of Formula I, including all the R -glyceryl, R1 to R13 groups, and m, n, q, and r subscript integers (see the exemplary compounds on page 3 lines 81-91, which includes glyceryl monomyristate, glyceryl monostearate, glyceryl monooleate, glyceryl monoisostearate, glyceryl monopalmitate, and glyceryl monopalmitooleate). The reference’s component (C), specifically salt(s) of a fatty acid, reads on the claimed second group of one or more salt compounds of Formula II, including all the R1 to R13 groups, m, n, q, and r subscript integers, and X cationic moiety (see the exemplary compounds on page 2 lines 59-75 of the machine translation, which includes and/or encompass sodium and potassium salts of lauric acid, myristic acid, palmitic acid, margaric acid, and stearic acid).
It is noted the reference discloses the component (C) is a “higher fatty acid and/or its salt”. In the event some picking and choosing of the component (C) is required (e.g., the presence of the fatty acid salt rather than 1) the fatty acid itself or 2) the fatty acid in combination with a fatty acid salt), at the time of the effective filing date it would have nevertheless been obvious to a person of ordinary skill in the art to provide the fatty acid salt by itself from the reference’s recitation of the conjunction “and/or” indicating the fatty acid salt present merely by itself is an express embodiment within the reference.
As to the claimed limitation(s) that the composition comprises 50-99.9 wt.% of the first compound(s) and 0.1-35 wt.% of the second compound(s), these limitation(s) are interpreted as broadly limiting the recited composition to include at least the two components in amounts relative to one another or in the solid-components in the composition, i.e., as an intermediate not including any additional solvent and/or liquid phase. It is noted the original specification indicates the compositions of the present invention function as emulsifiers that allow for the composition to be further dissolved, suspended, or dispersed in a solvent (e.g., paragraphs [0007] and [0047]). A composition of compounds/components containing the recited relative amounts of the first group and second group of compounds reads on the claim regardless of the presence of any additional solvent/liquid phase. Fukukura teaches the components (B), (C), and (D) are blended in respective weight ratios of 0.1-3 : 0.01-3 : 0.1-3 relative to 1 part of component (A) in order to obtain a satisfactorily emulsified composition (abstract and page 3 line 99-103 of the machine translation), which constitutes prima facie overlap of the claimed ranges of the first and second groups of compounds. Since there can be up to 3 parts by weight of the reference’s glycerin monofatty acid ester component (D) with 1 part by weight of component (A) and as little as 0.1 parts by weight component (B) and 0.01 parts by weight component (C), there can up to 73 wt.% of glycerin monofatty acid ester(s) in the composition (3 ÷ (1 + 0.1 + 0.01 + 3)), which overlaps the claimed range of the compound(s) of Formula I. The same rationale applies to there being an amount of the reference’s fatty acid salt component (C) being present in an amount overlapping the claimed range of the compound(s) of Formula II, too. For example, note that a hypothetical emulsifier blend of, in parts by weight, 0.1 parts component (B), 0.2 parts fatty acid salt (C), and 3 parts glycerin monofatty acid ester (D) all relative to 1 part component (A), which are all within the ratios/ranges of the reference, correspond to 71% by mass glycerin monofatty acid ester and 2% by mass fatty acid salt (3 ÷ (1 + 0.1 + 0.1 + 3) and 0.1 ÷ (1 + 0.1 + 0.1 + 3), respectively) and are would fall within the instantly claimed ranges.
Fukukura teaches the solvent is water (the emulsion comprises water, as described above; the aqueous component, i.e., water, may be added first with the emulsifier components, page 3 lines 109-110 of the machine translation).
Fukukura teaches the solvent is water, as described above. With regard to the solvent being at least 50% water by volume, note that the reference’s Examples demonstrate water is the majority of the liquid phase(s) of the emulsion and would be recognized by the skilled artisan to constitute well-within the claimed at least 50% water by volume range. See the Examples Table 1 in the original document demonstrating 10 parts by weight of oil (component 7 in Table 1) and the balance, i.e., in excess of 80 parts by weight, of water (component 8 in Table 1). See also Examples 13 and 14 (page 4 of the original document and page 4 line 153 to page 5 line 167 of the machine translation) each containing 10 parts by weight oil and balance water, i.e., about 85 parts by weight water and about 54 parts by weight water, respectively.
Fukukura teaches glyceryl monomyristate and glyceryl monostearate as exemplary compounds for component (D) in the reference (page 3 lines 81-91), which directly reads on the first group of compounds comprising one or more of the recited Markush group of alternate compounds.
Fukukura teaches the second group of compounds comprise SA-Na, PA-Na, MA-Na, SA-K, PA-K, or MA-K (a sodium, i.e., Na, or potassium, i.e., K, salt of stearic acid, i.e., SA, palmitic acid, i.e., PA, or myristic acid, i.e., MA, are exemplary compounds for component (C) in the reference, page 2 lines 59-75).
Regarding the claimed limitation that the concentration of the composition in the mixture is in a range of 0.5 to 200 mg/mL, note that the reference’s Examples demonstrate water is the majority of the liquid phase(s) of the emulsion and would be recognized by the skilled artisan to constitute the emulsifier components being well-within the claimed range of 0.5 to 200 mg/mL. See the Examples Table 1 in the original document demonstrating 10 parts by weight of oil (component 7 in Table 1) and the balance, i.e., in excess of 80 parts by weight, e.g., about 85 parts by weight as shown in Examples 1 and 2, of water (component 8 in Table 1). Depending on the density of the oil (assumed to generally be within the range of 0.8 g/L to 0.9 g/L), a basis of 100 grams of the entire emulsion contains about 95 g of water+oil or approximately 0.93 to 0.94 L of volume (85 g water × 1.0 g/L + 10 g oil × 0.8 to 0.9 g/L = 0.93 to 0.94 L), and about 5 grams of composition in approximately 0.93 to 0.94 L is about 5.3 to 5.4 to mg/mL. A similar rationale also applies to the reference’s Examples 13 and 14 (page 4 of the original document and page 4 line 153 to page 5 line 167 of the machine translation), In any event, Fukukura further teaches the blending amount of the component (A) is preferably 0.05 to 5% by mass of the entire emulsified composition (abstract and page 3 lines 92-94). This teaching in combination with teaching that the components (B), (C), and (D) are blended in respective weight ratios of 0.1-3 : 0.01-3 : 0.1-3 relative to 1 part of component (A) in order to obtain a satisfactorily emulsified composition, described above, further strongly overlaps and encompasses, if not also falls within the claimed concentration range.
Regarding the limitation that there are at least two compounds of the first group of compounds of Formula I, Fukukura page 3 lines 81-92 teaches the glycerin monofatty acid ester component (C) can be present alone or in combination of two or more .
Regarding the limitation that there are at least two compounds of the first group of compounds of Formula I, Fukukura page 3 lines 81-92 teaches the glycerin monofatty acid ester component (C) can be present alone or in combination of two or more.
Fukukura directly teaches the components (B), (C), and (D) are blended in respective weight ratios of 0.1-3 : 0.01-3 : 0.1-3 relative to 1 part of component (A) in order to obtain a satisfactorily emulsified composition, which constitutes prima facie overlap of parent claim 1’s claimed ranges of the composition comprising 50-99.9 wt.% of the first compound(s) and 0.1-35 wt.% of the second compound(s), as described above. The same teaching meets the instantly claimed limitation that the composition comprises a narrower range of 1-20 wt.% of the second compound(s).
Regarding the instantly claimed limitation that the composition comprises narrower ranges of 80-99 wt.% of the first compound(s), although Fukukura fails to explicitly teach the relative amount of the glycerin monofatty acid ester component (D) overlaps or is within this range, at the time of the effective filing date the claimed range would nevertheless be obvious to a person of ordinary skill in the art in view of Fukukura’s teachings. Fukukura teaches the ratio of components (the 0.1-3 (B) : 0.01-3 (C) : 0.1-3 (D) relative to 1 part of component (A), cited above) is merely a preferable, exemplary ratio of the components (see page 3 line 99) and the goal/purpose of the ratio between components A, B, C, and D is to merely obtain a composition where the components are “satisfactorily emulsified” and no precipitation of crystals of bile acid over time is observed (page 3 lines 100-103). Accordingly, at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to vary or increase (or try to vary or increase) the relative amount of the glycerin monofatty acid ester component (D) relative to the (A), (B), and (C) components and arrive at and/or within the claimed range of 50-99.8 wt.% of a glycerin monofatty acid ester(s) in order to obtain a composition that is satisfactorily emulsified and does not precipitate crystals of bile acid over time, i.e., stable. See MPEP 2123, I and II.
The rejection of Claims 39-41,44,46,127 under 35 U.S.C. 103 as being unpatentable over Fukukura et al is maintained. (JP 2519455 B2, hereinafter Fukukura) in view of Berge et al. (“Pharmaceutical Salts,” J. Pharm. Sci., 66(1), pages 1-19, 1977, hereinafter Berge). An English language machine translation of Fukukura has been provided with this correspondence.
Fukukura teaches an emulsion composition comprising, as solids/compounds in the emulsion, (A) a bile acid and/or its salt, (B) a sterol, (C) a higher fatty acid and/or its salt, and (D) a glycerin monofatty acid ester (abstract). The reference’s component (D) reads on the claimed first group of one or more compounds of Formula I, including all the R -glyceryl, R1 to R13 groups, and m, n, q, and r subscript integers (see the exemplary compounds on page 3 lines 81-91, which includes glyceryl monomyristate, glyceryl monostearate, glyceryl monooleate, glyceryl monoisostearate, glyceryl monopalmitate, and glyceryl monopalmitooleate). The reference’s component (C), specifically salt(s) of a fatty acid, reads on the claimed second group of one or more salt compounds of Formula II, including all the R1 to R13 groups, and m, n, q, and r subscript integers (see the exemplary compounds on page 2 lines 59-75 of the machine translation, which includes and/or encompass salts of lauric acid, myristic acid, palmitic acid, margaric acid, and stearic acid; page 2 lines 72-75 of the machine translation indicate the substance for forming the salt includes an a basic inorganic salt containing sodium ion, potassium ion, or the like).
It is noted the reference discloses the component (C) is a “higher fatty acid and/or its salt”. In the event some picking and choosing of the component (C) is required (e.g., the presence of the fatty acid salt rather than 1) the fatty acid itself or 2) the fatty acid in combination with a fatty acid salt), at the time of the effective filing date it would have nevertheless been obvious to a person of ordinary skill in the art to provide the fatty acid salt by itself from the reference’s recitation of the conjunction “and/or” indicating the fatty acid salt present merely by itself is an express embodiment within the reference.
As to the preamble’s recitation that the claimed composition is to a composition, note para. [0047] of the present application’s specification broadly indicates the meaning of the is that the composition can be non-toxic or toxic for human consumption. Fukukura teaches the composition is highly safe and natural and is an emulsifier composition composed of bio-derived, highly safe and natural components (see page 1 lines 32-35, page 3 lines 115-119, and page 5 lines 181-184), which meets the limitation that the composition is edible. Although the Office interprets the term “coating” as an intended use/purpose of the claimed composition or edible composition, Fukukura’s composition is drawn to cosmetic and pharmaceuticals, is capable of being spread, and is an emulsion, which all meet the claimed intended use/purpose limitation that the composition is a coating composition.
The exemplary salt(s) of a fatty acid described in Fukukura (e.g., a basic inorganic salt containing sodium ion, potassium ion, ammonium ion, or the like) read on the claimed second group of one or more salt compounds of Formula II where the Xp+ cationic moiety and charge state p where p is merely 1. It is noted the instant claim requires p be 2 or 3 rather than 1, and Fukukura fails to explicitly teach the p is 2 or 3.
However, Berge teaches typical and generally useful or acceptable salt-forming agents in the art. Table 1 on page 2 of Berge lists aluminum, calcium, and magnesium in a short list of metallic cation of FDA-approved commercially marketed salts among potassium and sodium. Thus, at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to provide aluminum, calcium, or magnesium as taught by Berge in place of the sodium or potassium of Fukukura because Berge teaches all of aluminum, calcium, magnesium, potassium, and sodium are art recognized equivalent metallic cations for forming salt compounds. At the time of the effective filing date, the selection of a particular cationic counter ion is merely a routine selection to a person of ordinary skill in the art in order to successfully form a salt compound. This combination of Fukukura in view of Berge encompasses aluminum, calcium, and/or magnesium salts of the exemplary compounds on page 2 lines 59-75 of the machine translation of Fukukura, which includes and/or encompass aluminum, calcium, and/or magnesium salts of lauric acid, myristic acid, palmitic acid, margaric acid, and stearic acid. Magnesium or calcium as the cation of the fatty acid salt reads on where p is 2, and aluminum as the cation of the fatty acid salt reads on where p is 3.
As to the claimed limitation(s) that the composition comprises 50-99.9 wt.% of the first compound(s) and 0.1-35 wt.% of the second compound(s), these limitation(s) are interpreted as broadly limiting the recited composition to include at least the two components in amounts relative to one another or in the solid-components in the composition, i.e., as an intermediate not including any additional solvent and/or liquid phase. It is noted the original specification indicates the compositions of the present invention function as emulsifiers that allow for the composition to be further dissolved, suspended, or dispersed in a solvent (e.g., paragraphs [0007] and [0047]). A composition of compounds/components containing the recited relative amounts of the first group and second group of compounds reads on the claim regardless of the presence of any additional solvent/liquid phase. Fukukura teaches the components (B), (C), and (D) are blended in respective weight ratios of 0.1-3 : 0.01-3 : 0.1-3 relative to 1 part of component (A) in order to obtain a satisfactorily emulsified composition (abstract and page 3 line 99-103 of the machine translation), which constitutes prima facie overlap of the claimed ranges of the first and second groups of compounds. Since there can be up to 3 parts by weight of the reference’s glycerin monofatty acid ester component (D) with 1 part by weight of component (A) and as little as 0.1 parts by weight component (B) and 0.01 parts by weight component (C), there can up to 73 wt.% of glycerin monofatty acid ester(s) in the composition (3 ÷ (1 + 0.1 + 0.01 + 3)), which overlaps the claimed range of the compound(s) of Formula I. The same rationale applies to there being an amount of the reference’s fatty acid salt component (C) being present in an amount overlapping the claimed range of the compound(s) of Formula II, too. For example, note that a hypothetical emulsifier blend of, in parts by weight, 0.1 parts component (B), 0.2 parts fatty acid salt (C), and 3 parts glycerin monofatty acid ester (D) all relative to 1 part component (A), which are all within the ratios/ranges of the reference, correspond to 71% by mass glycerin monofatty acid ester and 2% by mass fatty acid salt (3 ÷ (1 + 0.1 + 0.1 + 3) and 0.1 ÷ (1 + 0.1 + 0.1 + 3), respectively) and are would fall within the instantly claimed ranges.
Fukukura teaches glyceryl monomyristate and glyceryl monostearate as exemplary compounds for component (D) in the reference (page 3 lines 81-91), which directly reads on the first group of compounds comprising one or more of the recited Markush group of alternate compounds.
Fukukura in view of Berge teaches the second group of compounds comprise (SA)2-Mg, (PA)2-Mg, (MA)2-Mg, (SA)2-Ca, (PA)2-Ca, or (MA)2-Ca (as similarly described above, utilizing, providing, or substituting a magnesium, i.e., Mg, or calcium, i.e., Ca, cation as taught by Berge as the cation in Fukukura’s fatty acid salt component (C) read on the claimed compounds since stearic acid, i.e., SA, palmitic acid, i.e., PA, or myristic acid, i.e., MA, are exemplary compounds for component (C) of Fukukura, page 2 lines 59-75).
Fukukura teaches an oil-in-water emulsion composition comprising, as solids/compounds in the emulsion, (A) a bile acid and/or its salt, (B) a sterol, (C) a higher fatty acid and/or its salt, and (D) a glycerin monofatty acid ester (abstract, the Problems to be Solved by the Invention section on page 1, and page 3 lines 99-104). The reference’s components (A) to (D) read on the claimed composition, and the further combination of components (A) to (D) in oil and water read on the claimed mixture comprising a composition in a solvent. The reference’s component (D) reads on the claimed first group of one or more compounds of Formula I, including all the R -glyceryl, R1 to R13 groups, and m, n, q, and r subscript integers (see the exemplary compounds on page 3 lines 81-91, which includes glyceryl monomyristate, glyceryl monostearate, glyceryl monooleate, glyceryl monoisostearate, glyceryl monopalmitate, and glyceryl monopalmitooleate). The reference’s component (C), specifically salt(s) of a fatty acid, reads on the claimed second group of one or more salt compounds of Formula II, including all the R1 to R13 groups, and m, n, q, and r subscript integers (see the exemplary compounds on page 2 lines 59-75 of the machine translation, which includes and/or encompass salts of lauric acid, myristic acid, palmitic acid, margaric acid, and stearic acid; page 2 lines 72-75 of the machine translation indicate the substance for forming the salt includes an a basic inorganic salt containing sodium ion, potassium ion, or the like).
It is noted the reference discloses the component (C) is a “higher fatty acid and/or its salt”. In the event some picking and choosing of the component (C) is required (e.g., the presence of the fatty acid salt rather than 1) the fatty acid itself or 2) the fatty acid in combination with a fatty acid salt), at the time of the effective filing date it would have nevertheless been obvious to a person of ordinary skill in the art to provide the fatty acid salt by itself from the reference’s recitation of the conjunction “and/or” indicating the fatty acid salt present merely by itself is an express embodiment within the reference.
As to the claim’s recitation that the claimed composition component is an edible coating composition, note para. [0047] of the present application’s specification broadly indicates the meaning of the term edible is that the composition can be non-toxic for human consumption. Fukukura teaches the composition is highly safe and natural and is an emulsifier composition composed of bio-derived, highly safe and natural components (see page 1 lines 32-35, page 3 lines 115-119, and page 5 lines 181-184), which meets the limitation that the composition is edible. Although the Office interprets the term “coating” as an intended use/purpose of the claimed composition or edible composition, Fukukura’s composition is drawn to cosmetic and pharmaceuticals, is capable of being spread, and is an emulsion, which all meet the claimed intended use/purpose limitation that the composition is a coating composition.
The exemplary salt(s) of a fatty acid described in Fukukura (e.g., a basic inorganic salt containing sodium ion, potassium ion, ammonium ion, or the like) read on the claimed second group of one or more salt compounds of Formula II where the Xp+ cationic moiety and charge state p where p is merely 1. It is noted the instant claim requires p be 2 or 3 rather than 1, and Fukukura fails to explicitly teach the p is 2 or 3.
However, Berge teaches typical and generally useful or acceptable salt-forming agents in the art. Table 1 on page 2 of Berge lists aluminum, calcium, and magnesium in a short list of metallic cation of FDA-approved commercially marketed salts among potassium and sodium. Thus, at the time of the effective filing date it would have been obvious to a person of ordinary skill in the art to provide aluminum, calcium, or magnesium as taught by Berge in place of the sodium or potassium of Fukukura because Berge teaches all of aluminum, calcium, magnesium, potassium, and sodium are art recognized equivalent metallic cations for forming salt compounds. At the time of the effective filing date, the selection of a particular cationic counter ion is merely a routine selection to a person of ordinary skill in the art in order to successfully form a salt compound. This combination of Fukukura in view of Berge encompasses aluminum, calcium, and/or magnesium salts of the exemplary compounds on page 2 lines 59-75 of the machine translation of Fukukura, which includes and/or encompass aluminum, calcium, and/or magnesium salts of lauric acid, myristic acid, palmitic acid, margaric acid, and stearic acid. Magnesium or calcium as the cation of the fatty acid salt reads on where p is 2, and aluminum as the cation of the fatty acid salt reads on where p is 3.
As to the claimed limitation(s) that the composition comprises 50-99.9 wt.% of the first compound(s) and 0.1-35 wt.% of the second compound(s), these limitation(s) are interpreted as broadly limiting the recited composition to include at least the two components in amounts relative to one another or in the solid-components in the composition, i.e., as an intermediate not including any additional solvent and/or liquid phase. It is noted the original specification indicates the compositions of the present invention function as emulsifiers that allow for the composition to be further dissolved, suspended, or dispersed in a solvent (e.g., paragraphs [0007] and [0047]). A composition of compounds/components containing the recited relative amounts of the first group and second group of compounds reads on the claim regardless of the presence of any additional solvent/liquid phase. Fukukura teaches the components (B), (C), and (D) are blended in respective weight ratios of 0.1-3 : 0.01-3 : 0.1-3 relative to 1 part of component (A) in order to obtain a satisfactorily emulsified composition (abstract and page 3 line 99-103 of the machine translation), which constitutes prima facie overlap of the claimed ranges of the first and second groups of compounds. Since there can be up to 3 parts by weight of the reference’s glycerin monofatty acid ester component (D) with 1 part by weight of component (A) and as little as 0.1 parts by weight component (B) and 0.01 parts by weight component (C), there can up to 73 wt.% of glycerin monofatty acid ester(s) in the composition (3 ÷ (1 + 0.1 + 0.01 + 3)), which overlaps the claimed range of the compound(s) of Formula I. The same rationale applies to there being an amount of the reference’s fatty acid salt component (C) being present in an amount overlapping the claimed range of the compound(s) of Formula II, too. For example, note that a hypothetical emulsifier blend of, in parts by weight, 0.1 parts component (B), 0.2 parts fatty acid salt (C), and 3 parts glycerin monofatty acid ester (D) all relative to 1 part component (A), which are all within the ratios/ranges of the reference, correspond to 71% by mass glycerin monofatty acid ester and 2% by mass fatty acid salt (3 ÷ (1 + 0.1 + 0.1 + 3) and 0.1 ÷ (1 + 0.1 + 0.1 + 3), respectively) and are would fall within the instantly claimed ranges.
Fukukura teaches the solvent is water (the emulsion comprises water, as described above; the aqueous component, i.e., water, may be added first with the emulsifier components, page 3 lines 109-110 of the machine translation).
Fukukura teaches the solvent is water, as described above. With regard to the solvent being at least 50% water by volume, note that the reference’s Examples demonstrate water is the majority of the liquid phase(s) of the emulsion and would be recognized by the skilled artisan to constitute well-within the claimed at least 50% water by volume range. See the Examples Table 1 in the original document demonstrating 10 parts by weight of oil (component 7 in Table 1) and the balance, i.e., in excess of 80 parts by weight, of water (component 8 in Table 1). See also Examples 13 and 14 (page 4 of the original document and page 4 line 153 to page 5 line 167 of the machine translation) each containing 10 parts by weight oil and balance water, i.e., about 85 parts by weight water and about 54 parts by weight water, respectively.
Fukukura teaches each compound of the first group of compounds has a carbon chain length of at least 14 (glyceryl monomyristate and glyceryl monostearate, which contain a C14 chain and C16 chain, respectively, are exemplary compounds for component (D) in the reference, page 3 lines 81-91).
Fukukura in view of Berge teaches each compound of the second group of compounds has a carbon chain length of at least 14 (a magnesium, calcium, or aluminum salt of myristic acid or stearic acid, which contain a C14 chain and C16 chain, respectively, are exemplary compounds for component (C) in the combination of references; see page 2 lines 59-75 of Fukukura and Table 1 of Berge).
Fukukura in view of Berge teaches the second group of compounds comprise (SA)2-Mg, (PA)2-Mg, (MA)2-Mg, (SA)2-Ca, (PA)2-Ca, or (MA)2-Ca (as similarly described above, utilizing, providing, or substituting a magnesium, i.e., Mg, or calcium, i.e., Ca, cation as taught by Berge as the cation in Fukukura’s fatty acid salt component (C) read on the claimed compounds since stearic acid, i.e., SA, palmitic acid, i.e., PA, or myristic acid, i.e., MA, are exemplary compounds for component (C) of Fukukura, page 2 lines 59-75).
Fukukura teaches a “glycerin monofatty acid ester” as sufficient for the component (D), which reads on the claimed composition comprising less than 10% by mass of diglycerides or triglycerides. Fukukura is silent to the presence of any triglyceride, which further reads on the claimed composition comprising less than 10% by mass of triglycerides. It is noted the Fukukura’s abstract indicates component (D) is a glycerin monofatty acid ester “and/or” a glycerin difatty acid ester. However, in the event some picking and choosing of the component (D) is required (e.g., the presence of the glycerin monofatty acid ester, i.e., monoglyceride, rather than 1) a glycerin difatty acid ester, i.e., diglyceride, or 2) a glycerin monofatty acid ester in combination with a glycerin difatty acid ester, i.e., combination of monoglyceride and diglyceride) at the time of the effective filing date it would have nevertheless been obvious to a person of ordinary skill in the art to provide the monoglyceride/glycerin monofatty acid ester by itself free of any diglyceride/glycerin difatty acid ester from the from the primary reference’s recitation of the conjunction “and/or” indicating the monoglyceride/glycerin monofatty acid ester present merely by itself is an express embodiment within the primary reference.
Regarding the limitation that there are at least two compounds of the first group of compounds of Formula I, Fukukura teaches the glycerin monofatty acid ester component (C) can be present alone or in combination of two or more (page 3 lines 81-92).
Regarding the limitation that there are at least two compounds of the first group of compounds of Formula I, Fukukura teaches the glycerin monofatty acid ester component (C) can be present alone or in combination of two or more (page 3 lines 81-92).
Double Patenting Rejections - withdrawn
The rejection of Claims 39-47 on the ground of nonstatutory double patenting as being unpatentable over claims 18-28 of U.S. Patent No. 12,245,605 is withdrawn. Unlike instant claims presently reciting “monoacylglyceride” in the independent claim, US Patent 12,245,605 claims do not recite “monoacylglyceride” in an independent claim.
The rejection of Claims 1-25 on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,266,708 is withdrawn. Unlike instant claims reciting “monoacylglyceride” in an independent claim, US Patent 10,266,708 claims do not recite “monoacylglyceride” in an independent claim.
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/ALTON N PRYOR/Primary Examiner, Art Unit 1616