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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11 and 16-20) in the reply filed on 1/19/2026 is acknowledged.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/19/2026.
Claim Interpretation
Several claims set forth a method of measurement of various characteristics of the delivery system:
Claim 2: “measured using nitrogen and the BET method according to ISO 9277:2010”
Claim 3: “calculated from mercury porosimetry measurement”
Claim 4: “volume determined particle size”
Claim 16: “calculated from mercury porosimetry measurement”
The measured properties appear to be the same, irrespective of the measurement technique implemented. There is no evidence of criticality of the recited methods of measurement. As such, it is the Examiner’s position that prior art which discloses the appropriate property is regarded as reading on this limitation, regardless of how the property was measured.
Claim Objections
Claim 6 is objected to due the following, which appears to be a typographical error:
“the at least one active agent is adsorbed onto and/or adsorbed and/or adsorbed into the second hydromagnesite” (emphasis added). This appears to be a typographical error because “and/or adsorbed” is recited twice. For purposes of examination, this limitation is interpreted as requiring that the active agent is adsorbed onto and/or into the hydromagnesite.
Claim 18 is objected to for listing both “micro crystalline cellulose” (line 3 of the claim) and “microcrystalline cellulose” (line 5 of the claim). Thus, claim 18 recites microcrystalline cellulose twice, which appears to be a typographical error.
Claim Rejections - 35 USC § 102 or 35 USC § 103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim(s) 1, 5-7, 10-11, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Tanabe (Japanese Patent No. 2004161600 A) with reference to the provided machine translation (hereinafter “Tanabe”).
Regarding claim 1, Tanabe teaches a delivery system (e.g., hollow carriers and functional particles) [Tanabe Para. 0001] comprising:
A first hydromagnesite (e.g., a carrier which comprises particles of a basic magnesium carbonate having the formula mMgCO3·Mg(OH)2·nH2O wherein m is 4 and n is 4, which appears to meet the formula provided in the Specification Page 6 lines 10-15) [Tanabe Para. 0001 & 0004] and
A second hydromagnesite (e.g., a carrier which comprises particles of a basic magnesium carbonate having the formula mMgCO3·Mg(OH)2·nH2O wherein m is 4 and n is 4) [Tanabe Para. 0001 & 0004], wherein the second hydromagnesite is loaded with at least one active agent (e.g., the hollow carriers encapsulate a functional particle containing an active substance within the hollow carrier) [Para. 0023-24].
Tanabe does not explicitly state that the first hydromagnesite is an unloaded hydromagnesite. However, Tanabe describes the method for loading the hydromagnesites with the active agent: The amount of active substance introduced into the space in the carrier particle depends on the concentration of the substance [Para. 0082] and can be optimized by degassing or aspirating [Para. 0083] or even altering the inner diameter of the carrier [Para. 0082]. Further, Tanabe describes that the penetration of the solution of active agent may be insufficient [Para. 0083] depending on the conditions used for loading. As such, the description of partial penetration of the active agent into the hydromagnesite carrier appears to necessarily describe the situation wherein some amount is loaded and some amount is unloaded. As such, Tanabe’s description of insufficient impregnation of the active agent into the carrier is regarded as reading on this limitation.
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the concentration and air pressure during impregnation/loading of the hydromagnesite, thus resulting in an amount of unloaded hydromagnesite as claimed. One of ordinary skill in the art would have been motivated to do so because the concentration and pressure are taught to be result-effective variables regarding the stability of the tubular structure (e.g., if the viscosity is too high, there is a risk of breaking the tubular structure of the hydromagnesite) [Para. 0082].
Regarding claim 5, Tanabe teaches the delivery system wherein the first hydromagnesite and the second hydromagnesite are independently selected from the group consisting of ground natural hydromagnesite, precipitated hydromagnesite, surface-treated hydromagnesite, and mixtures thereof (e.g., precipitated hydromagnesite from magnesium salt and carbonate) [Para. 0035].
Regarding claim 6, Tanabe teaches the delivery system wherein the at least one active agent is adsorbed onto and/or adsorbed into the second hydromagnesite (e.g., the basic magnesium carbonate has a tubular structure which encapsulates the desired substance; the substance is embedded into the magnesium carbonate) [Para. 0081].
Regarding claim 7, Tanabe teaches the delivery system wherein the at least one active agent is an agrochemical active agent or a precursor thereof selected from the provided group (e.g., a nutrient, a food additive, a pharmaceutical, a pesticide, or a fertilizer) [Para. 0081].
Regarding claim 10, Tanabe teaches the delivery system further comprising a disintegration agent (e.g., digestive agents may be incorporated to create a formulation with controlled release properties) [Para. 0097], (the hollow carrier can be treated with advance with various substances such as fatty acids, resin acids, and coupling agents) [Para. 0118], (the surface can be further coated with organic polymers or starchy substances such as cellulosic polymers, starches, agar, alginate) [Para. 0111].
Regarding claim 11, Tanabe teaches the delivery system in the form of a powder, a tablet, a pellet, a bar, or granules (e.g., the functional particles can be granulated to form tablets, granules, pills, etc.) [Para. 0089].
Regarding claim 18, Tanabe teaches the delivery system wherein the disintegration agent is selected from the provided group (e.g., the surface can be further coated with organic polymers or starchy substances such as cellulosic polymers, starches, agar, alginate) [Para. 0111].
Regarding claim 20, Tanabe teaches the delivery system in the form of an effervescent tablet or fast disintegrating tablet (e.g., the functional particles can be granulated to form tablets, granules, pills, etc.) [Para. 0089] (the release rate can be controlled by controlling the length, inner diameter, and thickness of the magnesium carbonate [Para. 0162]; absent further definition of “fast disintegrating,” the release rate disclosed by Tanabe is regarded as reading on “fast”).
Claim Rejections - 35 USC § 103
Claim(s) 2-4, 8-9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanabe.
Regarding claim 2, Tanabe teaches the delivery system wherein the first hydromagnesite and/or the second hydromagnesite has a specific surface area in the range from 25 to 150 m2/g (e.g., 70 to 200 m2/g) [Para. 0005]. Note that similar or overlapping ranges create a prima facie case of obviousness. See MPEP 2144.05.
Regarding claim 3, Tanabe teaches the delivery system wherein the first hydromagnesite and/or the second hydromagnesite preferably has an intra-particle included specific pore volume in the range from 5000 to 12000 mm3/g [Para. 0027], which is outside the claimed range. However, Tanabe further teaches that the pore volume is a result-effective variable which depends on the pore diameter and length [Para. 0027] and affects the hollow carrier and release characteristics of the particles [Para. 0027-28]. The diameter can be a wide range from 0.5 to 10 microns, with a length of 5 to 500 microns. The diameter and length are importantly adjusted during the synthesis conditions of the basic magnesium carbonate [Para. 0037]. If the particles are too long (thereby increasing the pore volume), the time required in the second synthesis step may become extremely long, reducing manufacturing efficiency [Para. 0037]. The shape and size of the basic magnesium carbonate is controlled by the reaction temperature during synthesis [Para. 0039]. If the temperature is too high, the desired shape of particle may not be obtained, but if the temperature is too low, the reaction will proceed too slowly [Para. 0039]. As such, one of ordinary skill in the art would readily optimize the size and shape of the magnesium carbonate particles by optimizing the reaction conditions, thereby optimizing the pore volume. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in making the delivery system of Tanabe to optimize the pore volume to within the claimed range.
Regarding claim 4, Tanabe teaches the delivery system wherein the first hydromagnesite and/or the second hydromagnesite has a particle size from 1 to 75 microns and/or the first hydromagnesite and/or the second hydromagnesite has a top cut particle size from 2 to 250 microns (e.g., the hollow carrier preferably has an outer diameter of 1 to 20 microns, and a length of 5 to 200 microns) [Para. 0026]. Note that similar or overlapping ranges create a prima facie case of obviousness. See MPEP 2144.05.
Regarding claim 8, Tanabe teaches the delivery system wherein some of the hydromagnesite is loaded and some is not loaded as described in the rejection of claim 1 above, but does not explicitly describe that the second hydromagnesite is loaded with at least 1 wt. % of at least one active agent, based on the total weight of the second hydromagnesite. However, Tanabe teaches that the loading of the hydromagnesite is a result effective variable which depends on the surface area, pore volume, and pore distribution of the particle [Para. 0027-28]. Further, the amount of active substance introduced into the space in the carrier particle depends on the concentration of the substance [Para. 0082] and can be optimized by degassing or aspirating [Para. 0083] or altering the inner diameter of the carrier [Para. 0082]. Further, Tanabe describes that the penetration of the solution of active agent may be insufficient [Para. 0083] depending on the reaction conditions. As such, one of ordinary skill in the art would readily optimize the loading of the magnesium carbonate particles to within the broadly claimed range of at least 1% of at least one active agent. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in making the delivery system of Tanabe to optimize the loading of the second hydromagnesite to within the claimed range.
Regarding claim 9, Tanabe teaches the delivery system wherein some of the hydromagnesite is loaded and some is not as described in the rejection of claim 1 above, but does not explicitly describe that the first (unloaded) hydromagnesite is present in an amount from 1 to 99 wt. % and the second (loaded) hydromagnesite is present in an amount from 1 to 99 wt. %. However, Tanabe teaches that the loading of the hydromagnesite is a result effective variable which depends on the surface area, pore volume, and pore distribution of the particle [Para. 0027-28]. Further, the amount of active substance introduced into the space in the carrier particle depends on the concentration of the substance [Para. 0082] and can be optimized by degassing or aspirating [Para. 0083] or altering the inner diameter of the carrier [Para. 0082]. Further, Tanabe describes that the penetration of the solution of active agent may be insufficient [Para. 0083] depending on the reaction conditions. As such, one of ordinary skill in the art would readily optimize the loading of the magnesium carbonate particles such that the loaded and unloaded magnesium carbonates fall within the broadly claimed ranges of 1 to 99 wt. %. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in making the delivery system of Tanabe to optimize the loading of the hydromagnesites to within the claimed ranges.
Regarding claim 16, Tanabe teaches the delivery system wherein the first hydromagnesite and/or the second hydromagnesite has an intra-particle included specific pore volume in the range from 5000 to 12000 mm3/g [Para. 0027], which is outside the claimed range. However, Tanabe further teaches that the pore volume is a result-effective variable which depends on the pore diameter and length [Para. 0027] and affects the hollow carrier and release characteristics of the particles [Para. 0027-28]. The diameter can be a wide range from 0.5 to 10 microns, with a length of 5 to 500 microns. The diameter and length are importantly adjusted during the synthesis conditions of the basic magnesium carbonate [Para. 0037]. If the particles are too long (thereby increasing the pore volume), the time required in the second synthesis step may become extremely long, reducing manufacturing efficiency [Para. 0037]. The shape and size of the basic magnesium carbonate is controlled by the reaction temperature during synthesis [Para. 0039]. If the temperature is too high, the desired shape may not be obtained, but if the temperature is too low, the reaction will proceed slowly [Para. 0039]. As such, one of ordinary skill in the art would readily optimize the size and shape of the magnesium carbonate particles, thereby optimizing the pore volume. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in making the delivery system of Tanabe to optimize the pore volume to within the claimed range.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanabe as applied to claim 1 above, and further in view of Borzatta (U.S. Patent No. 8025894 B2, hereinafter “Borzatta”).
Regarding claim 17, Tanabe teaches that the delivery system can comprise active agents such as pesticides including insecticides and insect repellents [Para. 0107], but does not explicitly implement pyrimethanil, 2,4-D, etofenprox, and mixtures thereof. However, Borzatta teaches another encapsulated delivery formulation for plants which includes insecticides and insect repellents [Borzatta Abstract & Col. 4 lines 47-52]. Borzatta teaches that some of the most preferred compounds suitable as active agents in these encapsulated compositions include pyrimethanil and etofenprox [Borzatta Col. 5 lines 55-65]. As such, selecting these compounds from the limited number of preferred insecticides amounts to no more than choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in making the delivery system of Tanabe comprising insecticides to specifically choose pyrimethanil and/or etofenprox as taught by Borzatta.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanabe as applied to claims 1, 10, and 18 above, and further in view of Withiam (U.S. Patent Pub. No. 2003/0138369 A1, hereinafter “Withiam”).
Regarding claim 19, Tanabe teaches the delivery system comprising a disintegration agent such as carboxymethylcellulose in order to modify the surface properties of the delivery system and optimize the particles [Para. 0110 & 0112] but does not explicitly implement croscarmellose salt as the form of carboxymethylcellulose. However, Withiam teaches that standard disintegration materials for compacted solid forms such as tablets [Withiam Para. 0001] include crosslinked sodium carboxymethyl cellulose forms such as croscarmellose sodium [Withiam Para. 0026]. Other suitable agents include alginates and gums and other polymers [Withiam Para. 0026], which are also implemented by Tanabe. As such, selecting a croscarmellose salt from the limited number of forms of carboxymethylcellulose amounts to no more than choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in making the delivery system of Tanabe comprising carboxymethylcellulose to specifically choose croscarmellose salt as taught by Withiam.
Conclusion
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/H.E.R./ /JENNIFER A SMITH/Examiner, Art Unit 1731 Primary Patent Examiner, Art Unit 1731
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