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 .
Status of the Claims
Claims 20-22 have been cancelled.
Claims 1-19 and 23 are pending and currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on 12/10/2024 and 07/16/2026 are attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “PEGs>1000” in parentheses rendering the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP 2173.05(d).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7, 9-10, 12-14, 17-19 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harel et al. (US20120058195A1, Published 03/08/2012) as evidenced by Ascent Petrochem (Hydrogenated Palm Oil, Published 2026).
The Applicants claims are drawn to a double-layer coated microparticle for protecting a bioactive substance, comprising a core, an inner layer and an outer layer, wherein the core is coated with the inner layer and the outer layer, the inner layer is between the core and the outer layer, the core comprises the bioactive substance, the inner layer comprises a hydrophobic antioxidant, and the outer layer comprises a solid fat.
Regarding claims 1-7, Harel discloses in example 1, An agglomerating solution was prepared by dissolving 10 g sucrose and 1 g gum acacia in 100 g warm water (40-60° C.). To this was added 50 mg of sodium citrate and the solution cooled to room temperature. In a modified fluid bed dryer/granulator/coater system, equipped with air blower, variable air velocity and variable heat control, 1000 g of fine powder Vitamin A palmitate (i.e., bioactive substance, vitamin) was agglomerated by top spraying the agglomeration solution in fine mist for about 5 minutes with a two-fluid nozzle at an air pressure of 20 psi and a liquid rate of about 4 ml/min. The resulting agglomerated particles were air dried in the fluidized bed dryer to a residual moisture level of less than 3 percent using a drying temperature in the range of 50° C. to 60° C. The double layer coat was then applied starting with top spraying the emulsifier-rich inner layer until the mass of the particles increased by 20% of their original mass. The inner layer was composed of 40% (w/w) soy lecithin (i.e., emulsifier), 55% (w/w) hydrogenated soy oil and 5% (w/w) of Rosemary extract (i.e., hydrophobic antioxidant, herbs extracts). The solid fat-rich outer layer was then applied sequentially until the mass of the particles increased by 40% of their original mass. The outer layer was composed of 100% hydrogenated palm oil (i.e., solid fat, vegetable fat). The temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process and the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. FIG. 1 shows typical microparticles of the present invention and their retention stability in oil solution (paragraph [0053]).
Regarding claims 3 and 17, Harel discloses in example 1, The double layer coat was then applied starting with top spraying the emulsifier-rich inner layer until the mass of the particles increased by 20% of their original mass (paragraph [0053]). The preponderance of the evidence supports the conclusion that the inner layer is in an amount of 1-25 wt% because 60% of the particle is the core, then the particle mass increased by 20% once the inner layer was applied.
Regarding claim 6, Harel discloses in example 1, The solid fat-rich outer layer was then applied sequentially until the mass of the particles increased by 40% of their original mass. The outer layer was composed of 100% hydrogenated palm oil (i.e., solid fat) (paragraph [0053]). The preponderance of the evidence supports the conclusion that the outer layer is an amount of 20% because 60% of the particle is the core, then the particle mass increased by 20% once the inner layer was applied, then the outer layer is applied until the mass of the particles is increased by 40% of the original mass of particles.
Regarding claim 9, the examiner points out that the claim recites an intended use for the double-layer coated microparticle wherein the particle is store at a temperature below the melting temperature of the solid fat which does not limit the double-layer coated microparticle.
Regarding claims 10, 14, 18-19 and 23 Harel discloses in example 1, in a modified fluid bed dryer/granulator/coater system, equipped with air blower, variable air velocity and variable heat control, 1000 g of fine powder Vitamin A palmitate (i.e., bioactive substance, vitamin) was agglomerated by top spraying the agglomeration solution in fine mist for about 5 minutes with a two-fluid nozzle at an air pressure of 20 psi and a liquid rate of about 4 ml/min. The resulting agglomerated particles (i.e., core comprising a bioactive substance) were air dried in the fluidized bed dryer to a residual moisture level of less than 3 percent using a drying temperature in the range of 50° C. to 60° C. The double layer coat was then applied starting with top spraying the emulsifier-rich inner layer until the mass of the particles increased by 20% of their original mass. The inner layer was composed of 40% (w/w) soy lecithin (i.e., emulsifier), 55% (w/w) hydrogenated soy oil and 5% (w/w) of Rosemary extract (i.e., hydrophobic antioxidant, herbs extracts). The solid fat-rich outer layer was then applied sequentially until the mass of the particles increased by 40% of their original mass. The outer layer was composed of 100% hydrogenated palm oil (i.e., solid fat, vegetable fat). The temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process and the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. FIG. 1 shows typical microparticles of the present invention and their retention stability in oil solution (paragraph [0053]).
Regarding claim 12, Harel discloses in example 1, the temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process and the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. FIG. 1 shows typical microparticles of the present invention and their retention stability in oil solution (paragraph [0053]). As evidenced by Ascent Petrochem, Hydrogenated palm oil (i.e., solid fat) has a melting point of 58°C (Application of Hydrogenated Palm oil section). Therefore, Harel’s coating of the outer layer (i.e., step (b)) is carried out at a temperature above the melting temperature of the solid fat because as evidenced by Ascent Petrochem, hydrogenated palm oil has a melting point of 58°C and Harel discloses the temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process.
Regarding claim 13, Harel discloses in example 1, the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. As evidenced by Ascent Petrochem, Hydrogenated palm oil (i.e., solid fat) has a melting point of 58°C (Application of Hydrogenated Palm oil section). The preponderance of the of the evidence supports the conclusion that Harel’s double-layer coated microparticle is stored at a temperature below the melting temperature of the solid fat because as evidenced by Ascent Petrochem, hydrogenated palm oil has a melting point of 58°C and Harel teaches maintaining the microparticle at about 40° C, and then cooling, collecting, and sieving the microparticle, which would therefore be at a temperature below the melting temperature of the solid fat.
Accordingly, Haler anticipated the claimed 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable Harel et al. (US20120058195A1, Published 03/08/2012) as evidenced by Ascent Petrochem (Hydrogenated Palm Oil, Published 2026).
Applicant’s Invention
The Applicants claims are drawn to a double-layer coated microparticle for protecting a bioactive substance, comprising a core, an inner layer and an outer layer, wherein the core is coated with the inner layer and the outer layer, the inner layer is between the core and the outer layer, the core comprises the bioactive substance, the inner layer comprises a hydrophobic antioxidant, and the outer layer comprises a solid fat.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1-7, Harel teaches in example 1, An agglomerating solution was prepared by dissolving 10 g sucrose and 1 g gum acacia in 100 g warm water (40-60° C.). To this was added 50 mg of sodium citrate and the solution cooled to room temperature. In a modified fluid bed dryer/granulator/coater system, equipped with air blower, variable air velocity and variable heat control, 1000 g of fine powder Vitamin A palmitate (i.e., bioactive substance, vitamin) was agglomerated by top spraying the agglomeration solution in fine mist for about 5 minutes with a two-fluid nozzle at an air pressure of 20 psi and a liquid rate of about 4 ml/min. The resulting agglomerated particles were air dried in the fluidized bed dryer to a residual moisture level of less than 3 percent using a drying temperature in the range of 50° C. to 60° C. The double layer coat was then applied starting with top spraying the emulsifier-rich inner layer until the mass of the particles increased by 20% of their original mass. The inner layer was composed of 40% (w/w) soy lecithin (i.e., emulsifier), 55% (w/w) hydrogenated soy oil and 5% (w/w) of Rosemary extract (i.e., hydrophobic antioxidant, herbs extracts). The solid fat-rich outer layer was then applied sequentially until the mass of the particles increased by 40% of their original mass. The outer layer was composed of 100% hydrogenated palm oil (i.e., solid fat, vegetable fat). The temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process and the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. FIG. 1 shows typical microparticles of the present invention and their retention stability in oil solution (paragraph [0053]).
Regarding claims 3 and 17, Harel teaches in example 1, The double layer coat was then applied starting with top spraying the emulsifier-rich inner layer until the mass of the particles increased by 20% of their original mass (paragraph [0053]). The preponderance of the evidence supports the conclusion that the inner layer is in an amount of 1-25 wt% because 60% of the particle is the core, then the particle mass increased by 20% once the inner layer was applied.
Regarding claim 6, Harel teaches in example 1, The solid fat-rich outer layer was then applied sequentially until the mass of the particles increased by 40% of their original mass. The outer layer was composed of 100% hydrogenated palm oil (i.e., solid fat) (paragraph [0053]). The preponderance of the evidence supports the conclusion that the outer layer is an amount of 20% because 60% of the particle is the core, then the particle mass increased by 20% once the inner layer was applied, then the outer layer is applied until the mass of the particles is increased by 40% of the original mass of particles.
Regarding claims 8 and 16, Harel teaches to make the agglomerated microparticles, the agglomerating agent solution is usually introduced as a spray or mist and allows contacting with the agitated bioactive substance and to form agglomerated microparticles in a size range from 50-5000 micron (paragraph [0043]). Harel further teaches the layers deposited on the bioactive core increase the size of the bioactive agglomerate core at least two times and more preferably from about 2 to 10 times the size of the bioactive agglomerate core (i.e., 500-50,000 microns) (paragraph [0020]).
Regarding claim 9, the examiner points out that the claim recites an intended use for the double-layer coated microparticle wherein the particle is store at a temperature below the melting temperature of the solid fat which does not limit the double-layer coated microparticle.
Regarding claims 10, 14, 18-19 and 23 Harel teaches in example 1, in a modified fluid bed dryer/granulator/coater system, equipped with air blower, variable air velocity and variable heat control, 1000 g of fine powder Vitamin A palmitate (i.e., bioactive substance, vitamin) was agglomerated by top spraying the agglomeration solution in fine mist for about 5 minutes with a two-fluid nozzle at an air pressure of 20 psi and a liquid rate of about 4 ml/min. The resulting agglomerated particles (i.e., core comprising a bioactive substance) were air dried in the fluidized bed dryer to a residual moisture level of less than 3 percent using a drying temperature in the range of 50° C. to 60° C. The double layer coat was then applied starting with top spraying the emulsifier-rich inner layer until the mass of the particles increased by 20% of their original mass. The inner layer was composed of 40% (w/w) soy lecithin (i.e., emulsifier), 55% (w/w) hydrogenated soy oil and 5% (w/w) of Rosemary extract (i.e., hydrophobic antioxidant, herbs extracts). The solid fat-rich outer layer was then applied sequentially until the mass of the particles increased by 40% of their original mass. The outer layer was composed of 100% hydrogenated palm oil (i.e., solid fat, vegetable fat). The temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process and the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. FIG. 1 shows typical microparticles of the present invention and their retention stability in oil solution (paragraph [0053]).
Regarding claim 11, Harel teaches in example 1, an agglomerating solution was prepared by dissolving 10 g sucrose and 1 g gum acacia in 100 g warm water (40-60° C.). To this was added 50 mg of sodium citrate and the solution cooled to room temperature. In a modified fluid bed dryer/granulator/coater system (Fluid Air model 2, 2 liter max working capacity), equipped with air blower, variable air velocity and variable heat control, 1000 g of fine powder Vitamin A palmitate (BASF, Florham Park, N.J., particle size range from 0.5 micron to 10 micron) was agglomerated by top spraying the agglomeration solution in fine mist for about 5 minutes with a two-fluid nozzle at an air pressure of 20 psi and a liquid rate of about 4 ml/min. The resulting agglomerated particles were air dried in the fluidized bed dryer to a residual moisture level of less than 3 percent using a drying temperature in the range of 50° C. to 60° C (paragraph [0053]).
Regarding claim 12, Harel teaches in example 1, the temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process and the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. FIG. 1 shows typical microparticles of the present invention and their retention stability in oil solution (paragraph [0053]). As evidenced by Ascent Petrochem, Hydrogenated palm oil (i.e., solid fat) has a melting point of 58°C (Application of Hydrogenated Palm oil section). Therefore, Harel’s coating of the outer layer (i.e., step (b)) is carried out at a temperature above the melting temperature of the solid fat because as evidenced by Ascent Petrochem, hydrogenated palm oil has a melting point of 58°C and Harel discloses the temperature of the hydrogenated palm oil was maintained at 70° C. throughout the spraying process.
Regarding claim 13, Harel teaches in example 1, the particle temperature was maintained at about 40° C. The final step involved cooling the microparticles (i.e., double-layer coated microparticle), collecting and sieving the microparticles to a size range between 50 and 450 micron. As evidenced by Ascent Petrochem, Hydrogenated palm oil (i.e., solid fat) has a melting point of 58°C (Application of Hydrogenated Palm oil section). The preponderance of the of the evidence supports the conclusion that Harel’s double-layer coated microparticle is stored at a temperature below the melting temperature of the solid fat because as evidenced by Ascent Petrochem, hydrogenated palm oil has a melting point of 58°C and Harel teaches maintaining the microparticle at about 40° C, and then cooling, collecting, and sieving the microparticle, which would therefore be at a temperature below the melting temperature of the solid fat.
Regarding claim 15, Harel teaches to make the agglomerated microparticles, the agglomerating agent solution is usually introduced as a spray or mist and allows contacting with the agitated bioactive substance and to form agglomerated microparticles (i.e., core) in a size range from 50-5000 micron (paragraph [0043]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Harel does not disclose a single embodiment or example where every limitation recited in the instant claims are taught.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The claims are considered prima facie obvious to one of ordinary skill in the art because
Harel teaches all of the claimed elements. It would have been prima facie obvious at the time
of filing to have to a double-layer coated microparticle for protecting a bioactive substance, comprising a core, an inner layer and an outer layer, wherein the core is coated with the inner layer and the outer layer, the inner layer is between the core and the outer layer, the core comprises the bioactive substance, the inner layer comprises a hydrophobic antioxidant, and the outer layer comprises a solid fat because Harel teaches these elements as components of their invention.
With regards to claim 8 and 16, wherein the double-layer coated microparticle has a particle size of 500-10,000 µm, it would have been obvious to one of ordinary skill to optimize the particle size of the double-layer coated microparticle. One would have understood in view of Harel that to make the agglomerated microparticles, the agglomerating agent solution is usually introduced as a spray or mist and allows contacting with the agitated bioactive substance and to form agglomerated microparticles in a size range from 50-5000 micron (paragraph [0043]). Harel further teaches the layers deposited on the bioactive core increase the size of the bioactive agglomerate core at least two times and more preferably from about 2 to 10 times the size of the bioactive agglomerate core (i.e., 500-50,000 microns) (paragraph [0020]). Therefore, it would have been obvious to optimize to the particle size of the double-layer coated microparticle by routine experimentation to adjust the particle size using Harel’s teachings as a starting point for the desired results of the double layer coated microparticle. 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. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In addition, according to the MPEP, “It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker.” (MPEP 716.07).
With regards to claim 11, wherein step (a) is carried out at a temperature of 40-60°C, it would have been obvious to have step (a) be carried out at a temperature of 40-60°C in Harel’s method of making a double-layer coated microparticle. One would have understood in view of Harel that an agglomerating solution was prepared by dissolving 10 g sucrose and 1 g gum acacia in 100 g warm water (40-60° C.), the resulting agglomerated particles were air dried in the fluidized bed dryer to a residual moisture level of less than 3 percent using a drying temperature in the range of 50° C. to 60° C (example 1, paragraph [0053]). It would have been obvious to one of ordinary skill to have step (a) be carried out at a temperature of 40-60°C in Harel’s method of making a double-layer coated microparticle because Harel teaches in example 1 that the particle before application of the inner layer is dried at 50° C. to 60° C and the microparticle core was formed at 40-60° C. Therefore, it would have been obvious that when the inner layer is being applied, it would be carried out at a temperature of 40-60°C.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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