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 .
Detailed Action
Restriction/Election
Applicant's election with traverse of group I, claims 1-8 in the reply filed on 07/27/26 is acknowledged. Applicant’s election of polysaccharide ester and polyvinyl alcohol is also acknowledged. The traversal is on the ground(s) that the prior art used in the rejections does not teach the claimed parameters of the biodegradable particle. This is not found persuasive because Sakamoto et al. and Kobayashi et al. as discussed in detail below teach the claimed biodegradable particle comprising the biodegradable polymer with an expectation of obtaining similar parameters. The requirement is still deemed proper and is therefore made FINAL.
Claims 4 and 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected election/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/27/26.
Claim Rejections - 35 USC § 112, indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
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 1-3 and 5-6 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 pre-AIA the applicant regards as the invention. Claim 1 recites micrometer within parenthesis which makes the claim indefinite because whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 1 also recites the phrase ”major” which is a relative term. The term “major” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (WO2021/235352 A1, presented in IDS).
Sakamoto et al. (the claims) describes an "emulsifiable formulation that contains one or more water-based components selected from the group consisting of water and alcohols, an oil component, and micro particles of a polymer compound, wherein the micro particles contain a cellulose acetate as the polymer compound and the average particle diameter of the micro particles is 2-10 µm" (claim 1). In addition, Sakamoto et al. (the description) indicates that: "in addition, the micro particles may contain, not only the cellulose acetate, but also one or more types of other polymer compounds" (paragraph [0020]); "it is preferable that the other polymer compounds contained in the micro particles be biodegradable polymer compounds. Examples of the biodegradable polymer compounds include a polylactic acid, a polyglycolic acid, a polyaspartic acid, a polyvinyl alcohol, a polyhydroxyalkanoate, a modified polyethylene terephthalate, starch (glucose polymer), a cellulose derivative other than the cellulose acetate, a polybutylene succinate- based compound, a polycaprolactone, a gelatin, etc. In addition, in the case in which the emulsifiable formulation is for food and beverage products, the other polymer compounds may be, for example, edible polysaccharides" (paragraph [0022]); "the average particle diameter of the micro particles is 2-10 µm. The upper limit of the average particle diameter of the micro particles is preferably 8 µm and more preferably 7 µm. The lower limit of the average particle diameter of the micro particles is preferably 4 µm and more preferably 5 µm" (paragraph [0023]); "a plasticizer-impregnated cellulose acetate is obtained by mixing the cellulose acetate and a plasticizer. The total degree of acetyl substitution of the cellulose acetate is preferably 0.7 to 2.9, more preferably 1.4 or greater and less than 2.6, and even more preferably 2.0 and greater and less than 2.6" (paragraph [0029]); "kneading of the plasticizer-impregnated cellulose acetate and a water-soluble polymer can be performed by using, for example, an extruder, such as a twin screw extruder. The plasticizer- impregnated cellulose acetate and the water-soluble polymer are kneaded at 200-280°C. The kneaded material extruded in a string-like shape is cut so as to be formed into pellets, and thus, a dispersion is obtained. The obtained dispersion contains the water-soluble polymer as a dispersion medium and the plasticizer-impregnated cellulose acetate as a dispersoid" (paragraph [0039]); "a step for removing the water-soluble polymer from the obtained dispersion will be described. The water-soluble-polymer removal method is not particularly limited so long as it is possible to dissolve the water-soluble polymer and remove the water-soluble polymer from said particles. Examples of the water-soluble-polymer removal method include a method in which the water-soluble polymer in the dispersion is dissolved and removed by employing a removal solvent, such as water, an alcohol, such as methanol, ethanol, or isopropanol, or a mixed solution thereof. Specifically, there is a method in which, for example, the water-soluble polymer is removed from the dispersion by mixing the dispersion and the removal solvent and by filtering the mixture to remove residues" (paragraph [0040]); and "the emulsifiable formulation of the present disclosures can be configured as, for example, a sunscreen, a makeup base, a foundation, a lotion, a lipstick, a lip gloss, and a hair care product" (paragraph [0061]).
Furthermore, Sakamoto et al. (manufacturing example 1) indicates that: "100 parts by weight of a cellulose diacetate (a product of Daicel Corporation with a total degree of acetyl substitution DS of 2.4) and 25 parts by weight of triacetin, which serves as a plasticizer, were blended in a dry state, dried for 12 hours or longer at 80°C, and, additionally, stirred and mixed by employing a Henschel mixer to obtain a mixture of the cellulose acetate and the plasticizer. The obtained mixture was formed into kneaded material by being supplied to a twin screw extruder (PCM30, a product of Ikegai Corporation, at a cylinder temperature of 200°C and a die temperature of 220°C) to be melted, kneaded, and extruded to form pellets" (paragraph [0063]); "after 32 parts by weight of the obtained kneaded material, which is the pellets, and 68 parts by weight of a polyvinyl alcohol (a product of The Nippon Synthetic Chemical Industry Co., Ltd. with a melting point of 190°C and a saponification degree of 99.1%), which serves as the water-soluble polymer, were blended in a dry state, the mixture was supplied to the twin screw extruder (PCM30, a product of Ikegai Corporation, at a cylinder temperature of 220°C and a die temperature of 220°C) to be extruded to form a dispersion" (paragraph [0064]); and "the obtained dispersion was combined with pure water (solvent) so that the dispersion becomes 5 wt% ([weight of dispersion]/[weight of dispersion + weight of pure water] X 100) or less and the dispersion was stirred for 5 hours at a temperature of 80°C and a rotational speed of 500 rpm by employing a three-one motor (BL-3000, a product of Shinto Scientific Co., Ltd.). The stirred solution was filtered by using filter paper (a product of Advantech Co., Ltd., No. 5A) to remove residues. With the removed residues, pure water was used again for an adjustment so that the dispersion becomes 5 wt% or less, and, additionally, the dispersion was stirred for 5 hours at a temperature of 80°C and a rotational speed of 500 rpm and filtered to remove the residues, and said procedures were repeated for three times or more to obtain cellulose-acetate micro particles. The average particle diameter of the obtained cellulose-acetate micro particles was measured by means of the method described below" (paragraph [0065]). (See claims, paragraphs [0020], [0022], [0023], [0029], [0039], [0040], [0061], examples & TW 202207987 A, claims and examples).
Sakamoto et al. does not explicitly indicate the "flatness L/T" and the "surface smoothness" of the cellulose- acetate micro particles manufactured in manufacturing example 1. However, referring to the examples of the present application, it is understood that the particles manufactured via the steps specified in the invention as in claim 10 of the present application satisfy that "the flatness L/T, which is a ratio of the average long diameter L (µm) with respect to the average thickness T (µm), is 2.0 or greater and the surface smoothness is 80% or greater". As examined in (b)-(f), indicated above, the cellulose-acetate micro particles manufactured in manufacturing example 1 of Sakamoto et al., described above, are also manufactured via the same steps as the steps specified in the invention as in claim 10 of the present application; therefore, said cellulose-acetate micro particles are considered to satisfy that the "flatness L/T, which is a ratio of the average long diameter L (µm) with respect to the average thickness T (µm), is 2.0 or greater and the surface smoothness is 80% or greater". In view thereof, there is no difference between the invention as in claims 1-12 of the present application and the invention described in Sakamoto et al. in terms of the invention-specifying matters, and, in addition, a person skilled in the art could easily have made said invention on the basis of the invention described in the reference.
Thus, the art teaches use of a biodegradable flattened particle comprising a biodegradable polymer. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making a biodegradable flattened particle comprising a polymer such as a polysaccharide, with an expectation of obtaining the parameters substantially similar to one claimed because the process taught by the prior art is substantially similar, see MPEP 2143 part (I)(A).
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi et al. (WO2019/156116 A1, presented in IDS).
Kobayashi et al. (the claims) describes: "cellulose acetate particles, wherein the cellulose acetate particles has an average particle diameter of 80 nm to 100 µm, a sphericity of 0.7 to 1.0, and a surface smoothness of 80 to 100%, and the total degree of acetyl substitution of cellulose acetate is 0.7 to 2.9" (claim 1); "a cosmetic composition containing the cellulose acetate particles set forth in any one of claims 1-4" (claim 5); and "a cellulose-acetate-particle manufacturing method comprising: a step for obtaining plasticizer-impregnated cellulose acetate by mixing a cellulose acetate, in which the total degree of acetyl substitution is 0.7 to 2.9, and a plasticizer, a step for obtaining a dispersion in which the plasticizer-impregnated cellulose acetate is dispersoid by kneading the plasticizer-impregnated cellulose acetate and a water-soluble polymer at 200-280°C, and a step for removing the water-soluble polymer from the dispersion" (claim 6). In addition, Kobayashi et al. (the description) indicates that: "although the surface smoothness of the cellulose acetate particles of the present disclosure is 80 to 100%, the surface smoothness is preferably 85 to 100% and more preferably 90 to 100%. Setting the surface smoothness to be less than 80% results in deterioration of the tactile feeling. Setting the surface smoothness to be closer to 100% results in a preferable tactile feeling" (paragraph [0035]); "the water-soluble polymer in this description refers to a polymer in which insoluble components are less than 50 wt% when 1 g of the polymer is dissolved in 100 g of water at 25°C. Examples of the water-soluble polymer include a polyvinyl alcohol, a polyethylene glycol, a sodium polyacrylate, a polyvinylpyrrolidone, a polypropylene oxide, a polyglycerine, a polyethylene oxide, a vinyl acetate, a modified starch, thermoplastic starch, a methyl cellulose, an ethyl cellulose, a hydroxyethyl cellulose, and a hydroxypropyl cellulose. Among these, a polyvinyl alcohol, a polyethylene glycol, and thermoplastic starch are preferable, and a polyvinyl alcohol and thermoplastic starch are particularly preferable" (paragraph [0067]).
Furthermore, Kobayashi et al. (example A-1) indicates that: "100 parts by weight of a cellulose diacetate (a product of Daicel Corporation with a total degree of acetyl substitution DS of 2.4) and 25 parts by weight of triacetin, which serves as a plasticizer, were blended in a dry state, dried for 12 hours or longer at 80°C, and, additionally, stirred and mixed by employing a Henschel mixer to obtain a mixture of the cellulose acetate and the plasticizer. The obtained mixture was formed into a kneaded material by being supplied to a twin screw extruder (PCM30, a product of Ikegai Corporation, at a cylinder temperature of 200°C and a die temperature of 220°C) to be melted, kneaded, and extruded to form pellets" (paragraph [0078]); "after 30 parts by weight of the obtained kneaded material, which is the pellets, and 70 parts by weight of a polyvinyl alcohol (a product of The Nippon Synthetic Chemical Industry Co., Ltd. with a melting point of 190°C and a saponification degree of 99.1%), which serves as the water-soluble polymer, were blended in a dry state, the mixture was supplied to the twin screw extruder (PCM30, a product of Ikegai Corporation, at a cylinder temperature of 220°C and a die temperature of 220°C) to be extruded to form a dispersion" (paragraph [0079]); and "the obtained dispersion was combined with pure water (solvent) so that the dispersion becomes 5 wt% ([weight of dispersion]/[weight of dispersion + weight of pure water] X 100) or less and the dispersion was stirred for 3 hours at a temperature of 80°C and a rotational speed of 100 rpm by employing a three-one motor (BL-3000, a product of Shinto Scientific Co., Ltd.). The stirred solution was filtered by using filter paper (a product of Advantec Co., Ltd., No. 5A) to remove residues. With the removed residue, pure water was used again for an adjustment so that the dispersion becomes 5 wt% or less, and, additionally, the dispersion was stirred for 3 hours at a temperature of 80°C and a rotational speed of 100 rpm and filtered to remove the residues, and said procedures were repeated for three times or more to obtain cellulose acetate particles" (paragraph [0080]). Here, the invention described in document 2 and the invention as in claims 1-6 and 9-12 of the present application will be compared.
(a) The cellulose diacetate contained in the cellulose acetate particles manufactured in example A-1 of Kobayashi et al. corresponds to "the biodegradable polymer" of the invention as in claim 1 of the present application and "the polysaccharide or the polysaccharide ester", of the invention as in claim 3 of the present application. In addition, the total degree of acetyl substitution of the aforementioned cellulose diacetate is 2.4; therefore, the range defined in the invention as in claim 5 of the present application, wherein "the total degree of substitution of the polysaccharide ester is greater than 0 and equal to or less than 3.0", is satisfied.
(b) In example A-1 of Kobayashi et al., described above, the procedures wherein "a cellulose diacetate and 25 parts by weight of triacetin, which serves as a plasticizer, were blended in a dry state, and, additionally, stirred and mixed by employing a Henschel mixer to obtain a mixture of the cellulose acetate and the plasticizer. The obtained mixture was formed into a kneaded material by being supplied to a twin screw extruder to be melted, kneaded, and extruded to form pellets. 30 parts by weight of the obtained kneaded material, which is the pellets, and a polyvinyl alcohol, which serves as the water-soluble polymer, were blended in a dry state" correspond to the step for "mixing a biodegradable polymer, a plasticizer, and a water-soluble polymer to obtain a mixture" in the invention as in claim 10 of the present application.
(c) In example A-1 of Kobayashi et al., described above, the procedure wherein the mixture was "supplied to a twin screw extruder (PCM30, a product of Ikegai Corporation, at a cylinder temperature of 220°C and a die temperature of 220°C)" corresponds to the step for "obtaining a kneaded material by melting and kneading the mixture at 200-280°C" in the invention as in claim 10 of the present application. (d) In example A-1 of Kobayashi et al., described above, the procedure wherein the mixture was "extruded to form a dispersion" involves application of pressure to the kneaded material; therefore, said procedure corresponds to the step for "applying pressure to the kneaded material at a temperature that is less than the melting point of the water-soluble polymer" in the invention as in claim 10 of the present application. (e) In example A-1 of Kobayashi et al., described above, the procedure wherein the mixture was "extruded to form a dispersion" involves application of pressure to the kneaded material when the kneaded material is extruded; therefore, said procedure corresponds to the step for "applying pressure to the kneaded material at a temperature that is less than the melting point of the water-soluble polymer" in the invention as in claim 10 of the present application. (f) In example A-1 of Kobayashi et al., described above, the procedures wherein "the obtained dispersion was combined with pure water (solvent) so that the dispersion becomes 5 wt% ([weight of dispersion]/[weight of dispersion + weight of pure water] X 100) or less and the dispersion was stirred. The stirred solution was filtered to remove residues. With the removed residues, pure water was used again for an adjustment so that the dispersion becomes 5 wt% or less, and, additionally, the dispersion was stirred for 3 hours at a temperature of 80°C and a rotational speed of 100 rpm and filtered to remove the residues, and said procedures were repeated for three times or more" correspond to the step for "removing the water-soluble polymer from the pressurized kneaded material" in the invention as in claim 10 of the present application. (g) According to the examples on table 1 of Kobayashi et al. (paragraph [0116]), the surface smoothness of the cellulose acetate particles manufactured in example A-1 is 100%; therefore, said cellulose acetate particles satisfy the range defined in the invention as in claim 1 of the present application, wherein the "surface smoothness is 80% or greater". (h) Kobayashi et al. does not explicitly indicate the "flatness L/T" of the cellulose acetate particles manufactured in example A-1. However, referring to the examples of the present application, it is understood that the particles manufactured via the steps specified in the invention as in claim 10 of the present application satisfy that "the flatness L/T, which is a ratio of the average long diameter L (µm) with respect to the average thickness T (µm), is 2.0 or greater". As examined in (b)-(f), described above, the cellulose acetate particles manufactured in example A-1 of Kobayashi et al., described above, are also manufactured via the same steps as the steps specified in the invention as in claim 10 of the present application; therefore, said cellulose acetate particles are considered to satisfy that the "flatness L/T, which is a ratio of the average long diameter L (µm) with respect to the average thickness T (µm), is 2.0 or greater". A person skilled in the art could easily have made said invention on the basis of the invention described in Kobayashi et al., see (claims, paragraphs [0035], [0067], examples & US 2020/0179261 A1, claims, paragraphs [0038], [0071], examples & EP 3613794 A1, claims, paragraphs [0032], [0065] and examples (1)).
Thus, the art teaches use of a biodegradable flattened particle comprising a biodegradable polymer. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making a biodegradable flattened particle comprising a polymer such as a polysaccharide, with an expectation of obtaining the parameters substantially similar to one claimed because the process taught by the prior art is substantially similar, see MPEP 2143 part (I)(A).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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