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
Previous Rejections
Applicants' arguments, filed 08/20/25, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim 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 1-2, 4-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (Journal of Cereal Science 50 (2009) 99–105; Formation of kafirin microparticles by phase separation from an organic acid and their characterization) in view of Taylor et al. (WO 2010/041203) and further in view of Frank et al. (US 2024/0016147A1).
Taylor teaches that kafirin, the sorghum prolamin storage protein (source of natural nutrient source) has been found to be similar to zein microspheres, see introduction. The reference teaches preparation of kafirin microparticles with acetic acid wherein it is taught that Plasticizer (0.66 g of 1:1:1 lactic acid, polyethylene glycol 400, glycerol) equivalent to 40% in relation to protein was mixed with 4.34 g glacial acetic acid (98%) and added to kafirin (1.8 g, 88% protein, as is basis) with gentle stirring using a magnetic stirrer. The temperature was slowly raised to 30 degrees C to ensure full solvation of the kafirin. This solution was then allowed to ‘rest’ for 16h to give time for any changes in protein structure to equilibrate. After this period, distilled water at ambient temperature was added slowly over a period of 5 min with stirring to a total weight of 80 g. During addition of the water, microparticles were formed. The final concentration of protein was 2% (w/w), with an acetic acid concentration of 5.4% (w/w). Freeze dried microparticles were prepared by removing the acid by centrifugation and washing the pellet of microparticles three times with distilled water. The supernatant was removed before freeze drying the resultant pellet, (see 2.2.1., preparation of kafirin microparticles in left column). This method provides advantage of having open structures/matrix and could find applications in support matrices, see (conclusions section). (Thus, the reference teaches sorghum kafirin (which is similar to zein) microparticle preparation; wherein it uses glycerol, lactic acid and polyethylene glycol, which serves as an efficient matrix material).
Taylor does not teach use of active ingredients within the matrix.
Taylor ‘203 while teaching the same biodegradable microparticle comprising glycerol, lactic acid and polyethylene glycol, as Taylor (primary reference) suggests addition of active ingredients, see abstract and claims 1, 14 and 16. Taylor teaches that the formation of microparticles with a range of sizes allows for multiple applications. This includes food uses, e.g. film formation for food packaging, edible coatings for the prolongation of shelf-life of food products, and encapsulation of, for example, foodstuffs, animal feed products, food ingredients, enzymes, hormones, colouring agents, flavouring agents, trace minerals, nutrients, pharmaceuticals, nutraceuticals, probiotics, and prebiotics. Other nonfood uses could include drug delivery, other medical uses such as tissue engineering, tissue matrixes or scaffolds and coatings for cardiovascular and other biomedical devices, biological semi-conductors and delayed release of pesticides and fertilizers, see page 10, last paragraph.
Frank as discussed below teaches active ingredients inside a biodegradable microparticle.
Frank teaches biodegradable, bioactive biopolymer coating platforms, compositions and methods of making such in microparticle to nanoparticulate form, see abstract and [0166]. Frank discloses that the microparticles or the microspheres of the present disclosure have an average geometric particle size of less than 200 microns. The particle size is from about 0.01 μm to about 200 μm, from about 0.1 μm to about 100 μm, from about 0.5 μm to about 50 μm, and from about 0.5 μm to about 10 μm, see [0166]. The reference teaches that in an embodiment, the agricultural agents or agricultural active ingredients are loaded into microparticles (such as minicells, colloidal carriers) and the agent-loaded microparticles are coated, covered, protected or encapsulated by a biopolymer layer taught herein and in further embodiments, the surface of the agent-loaded microparticles are coated, covered, protected or encapsulated by a biopolymer layer taught herein, see [0182]. By utilizing active ingredient inside a coating, the release of the active can be released in a targeted site, see [0199]. The agricultural or bioactive agent is loaded into the microparticle which can be agricultural or bioactive agent, see claims 12, 75 and [0270]. The reference teaches that wherein said agricultural agent is a pesticidal agent, an insecticidal agent, a herbicidal agent, a fungicidal agent, a virucidal agent, a nematicidal agent, a molluscicidal agent, an antimicrobial agent, an antibacterial agent, an antifungal agent, an antiviral agent, an antiparasitic agent, a fertilizing agent, a repellent agent, a plant growth regulating agent, or a plant-modifying agent, see claim 20.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized an active ingredient such as a repellent agent, agricultural agent, bioactive agent, an antibacterial agent or a pesticidal agent as taught by Frank et al. inside the biodegradable matrix of Taylor et al. One of ordinary skill would have been motivated to do so because Taylor teaches that microspheres made up of (lactic acid, glycerol and polyethylene glycol) provides advantage of having open structure/matrix and could applications in support matrices, Taylor ‘203 while teaching similar microspheres a Taylor (primary reference) teaches addition of various active ingredients and Frank teaches the known active ingredients can be loaded into the known biodegradable, bioactive biopolymer polymeric microparticles.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (Journal of Cereal Science 50 (2009) 99–105; Formation of kafirin microparticles by phase separation from an organic acid and their characterization) in view of Taylor et al. (WO 2010/041203) and further in view of Frank et al. (US 2024/0016147A1) and ZHANG, B. et al., (“Development of Silver-Zein Composites as a Promising Antimicrobial Agent’, Biomacromolecules, 2010, vol. 11, pages 2366-2375).
While Frank et al. as discussed above teach use of antimicrobial agent, the references discussed above do not specifically teach use of silver in the microparticle.
Zhang teaches silver-zein composites as a promising antibacterial agents (see title and abstract).
It would have been obvious to one of ordinary skill to have utilized active ingredient such as silver for antimicrobial properties and have included into the matrices of Taylor et al. as modified by Taylor ‘203 and Frank et al. One of ordinary skill would have been motivated to do so because Taylor teaches preparation of sorghum comprising matrices which have larger voids, Frank teaches that antimicrobials can be included in the biodegradable coatings for controlled release and targeted release and Zhang teaches use of silver with zein for its intrinsic antimicrobial properties.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (Journal of Cereal Science 50 (2009) 99–105; Formation of kafirin microparticles by phase separation from an organic acid and their characterization) in view of in view of Taylor et al. (WO 2010/041203) and further in view of Frank et al. (US 2024/0016147A1) and Shasha et al. (USP 5,837,273A).
The references discussed above do not each use of a protective coating.
Shasha et al. discloses granules encapsulating a biologically active agent comprising starch from corn flour (maize as claimed and corn flour will implicitly include corn zein), corn starch or potato amylopectin and an active agent encapsulated in said starch, wherein granular starch-encapsulated agents can be coated with an additional layer of pregelatinized starch (see column 8, lines 1-17; examples 1, 2; claims 1, 6). Shasha et al. discloses that starch is from corn flour, corn starch or potato amylopectin (see claim 1); and the biologically active agent is a chemical insecticide or Bacillus thuringiensis or pesticide or insecticide (see claims 7, 9 and 4). Shasha et al. discloses that an active agent is encapsulated in the starch (see claim 1). Shasha et al. discloses that granular starch-encapsulated agents can be coated with an additional layer of pregelatinized starch (see column 8, lines 1-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have encapsulated the biodegradable kafirin or active ingredient comprising microparticle as taught by Taylor as modified by Taylor ‘203 and Frank et al. with a protective coating since as Shasha et al. a known process of coating with corn starch. Utilization of known component by known method would have provided a predictable protective coating layer.
Applicant ‘s arguments are moot in view of new rejections made above necessitated by claim amendments.
Action is final
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.
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