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 .
Priority
The instant application was filed 05 February 2024. The Applicant does not claim priority to other applications. The effective filing date of the instant application is 05 February 2024.
Examiner’s Note
The Applicant's amendments and arguments filed 30 July 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 30 July 2026, it is noted that claim 1 has been amended and no claims have been canceled or newly added. Support for the amendment can be found in para. 35 of the specification. No new matter has been added.
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 9 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 9 recites a plurality of nanoparticles that “further comprise geraniol.” Geraniol is already included in the composition in independent claim 1. The claim is indefinite because the metes and bounds of the limitation cannot be determined.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shakeel (US 20230044257 A1) in view of Alkekhia et al. (Layer-by-Layer Biomaterials for Drug Delivery, Annu. Rev. Biomed. Eng., 2020).
Regarding claim 1, Shakeel teaches a pesticidal composition (para. 98) that may comprise geraniol (para. 9) and an essential oil (para. 10), such as a botanical essential oil/active ingredient (para. 56), within minicells (abs; entire teaching), which are membrane-encapsulated biological nanoparticles (para. 93). The suspension comprising 0.01 to 5,000 mg of minicells per mL (para. 212) is interpreted as a “plurality of nanoparticles.” The minicell comprising the active agents may be coated in chitosan (para. 198). The composition may be used on chickens (para. 42), where the compositions may provide benefits for egg shell thickness (para. 130), which is understood to mean a chicken with an egg. The composition is used as a pesticide to target mites (para. 40). The limitation of “a pesticide formulation used to control chicken red mites on a chicken, the chicken containing an egg” is interpreted as intended use and is given minimal patentable weight. See MPEP 2111.02(II). The minicell delivering the active agents to a target (para. 202) and also providing benefits for egg shell thickness (para. 130) is interpreted as addressing a pesticide formulation that does not translocate to the egg. Additionally, the limitation of “the pesticide formulation does not translocate to the egg inside the chicken” is interpreted as a functional limitation of the formulation. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding Applicant’s amendment to claim 1, the limitation of the chitosan layer “configured to degrade according to time, pH, polarity” is interpreted as a functional limitation of the chitosan layer and is given minimal patentable weight. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding claim 2, Shakeel describes a method of producing the minicell using chitosan solution in acetic acid (para. 255).
Regarding claim 3, Shakeel teaches about 0.1% (0.1 x 10,000 = 1000 ppm) of active agents is encapsulated by the minicell (para. 9).
Regarding claim 4, the essential oil may be thyme oil (para. 56).
Regarding claim 5, the diameter of the minicell may have a diameter of 10-1000 nm (para. 97).
Regarding claim 6, Shakeel describes several centrifugation steps for making the minicells (para. 223, examples). Additionally, the limitation of “the nanoparticles are created using a centrifuge” is interpreted as a product-by-process limitation and is given minimal patentable weight. See MPEP 2113(I).
Regarding claim 7, the minicells are processed using emulsifiers, such as Tween 80 (para. 250), which is interpreted similarly to a surfactant. Furthermore, Shakeel teaches that surfactants are generally used with terpenes (para. 112).
Regarding claim 8, the composition may further include water (para. 100).
Regarding claim 9, the minicells may comprise geraniol (para. 55).
Regarding claim 10, Shakeel teaches about 0.1% (0.1 x 10,000 = 1000 ppm) of active agents is encapsulated by the minicell (para. 9).
Shakeel does not specifically teach more than one layer of chitosan to encapsulate the nanoparticles in claim 1.
In regards to selecting the combination of ingredients and layers recited in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Shakeel teaches a pesticidal composition (para. 98) that may comprise geraniol (para. 9) and an essential oil (para. 10), such as a botanical essential oil/active ingredient (para. 56), within minicells (abs; entire teaching), which are membrane-encapsulated biological nanoparticles (para. 93), whereas the claimed invention is directed towards a pesticide formulation comprising a plurality of nanoparticles containing one or more botanical active ingredient and a plurality of chitosan encapsulation layers. Since Shakeel teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Alkekhia teaches layer-by-layer technology, such as coatings for nanoparticles (pg. 1, entire teaching), is used for controlled drug delivery (abs), as well as increased stability and biocompatibility (pg. 5). Naturally derived polymers, such as chitosan, are commonly used (pg. 3).
Since Shakeel does not specifically teach more than one layer of chitosan to encapsulate the nanoparticles in claim 1, it would have been obvious to a skilled artisan to include multiple layers of coating on the nanoparticle composition in Shakeel with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings and improve Shakeel’s nanoparticle composition because Alkekhia teaches several benefits, such as controlled drug delivery, when multiple layers of coatings are used on nanoparticles. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6, 7, 11, 12, 16, 17, 18, 20, 21 of copending Application No. 18/484,603 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference application recites a pesticide formulation comprising a plurality of nanoparticles, chitosan, geraniol, wherein each of the nanoparticles are wrapped in the chitosan (claim 1). The nanoparticles further comprise oxymatrine (claim 2) and peppermint oil (claim 6). The composition is used to control mites (claim 7) or chicken red mites (claim 11). The concentration of geraniol oil is 50-4000 ppm (claim 16), the nanoparticle diameter is 20-200 nm (claim 17). The nanoparticles are created using a centrifuge (claim 18). The formulation comprises at least one of a filler, an extender, a wetting agent, a disintegrant, and a surfactant (claim 20), wherein the aforementioned components include alcohol, water, dextrin, calcium carbonate, lactose, propylene glycol, liquid paraffin, and saline (claim 21).
The instant claims are similar and obvious over the reference application’s claims. The instant claims recite a pesticide formulation to control chicken red mites, comprising a plurality of nanoparticles, chitosan, geraniol and an essential oil, wherein each nanoparticle is wrapped in chitosan and the pesticide formulation does not translocate to the egg of a chicken (instant claim 1). The chitosan is in a chitosan solution (instant claim 2). Geraniol is at a concentration of 50-4000 ppm (instant claim 3). The essential oil includes oxymatrine, peppermint oil, thyme oil, etc. (instant claim 4). The nanoparticles have a diameter of 20-200 nm (instant claim 5). The nanoparticles are created using a centrifuge (instant claim 6). The formulation further comprises an extender, a wetting agent, a disintegrant, or a surfactant (instant claim 7). The aforementioned components include alcohol, water, dextrin, calcium carbonate lactose, propylene glycol, liquid paraffin, and saline (instant claim 8). The nanoparticles further comprise at least one of geraniol and oxymatrine (instant claim 9). The nanoparticles comprise geraniol at a concentration of 50-4000 ppm (instant claim 10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-14 of copending Application No. 18/484,622 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference application recites a pesticide formulation comprising nanoparticles, chitosan, garlic oil, castor oil, lemongrass oil, wherein the nanoparticles are wrapped in chitosan (claim 1). The formulation is an insecticide, which is interpreted as intended use (claim 2). The formulation is used to control mosquitos and midges (claim 3). Claim 4 recites certain species of mosquitoes (claim 4), where the formulation used to treat or control mosquitoes is interpreted as intended use. The chitosan is in a chitosan solution (claim 5). The garlic oil, castor oil, lemongrass oil, and cedarwood oil are at a concentration of 50-4000 ppm (claims 6 and 7). The nanoparticles have a diameter of 20-200 nm (claim 9). The nanoparticles are created using a centrifuge (claim 10). The formulation is used in an environment, such as a field, lawn, forest, etc., which is interpreted as intended use (claim 11). The formulation comprises at least one of a filler, an extender, a wetting agent, a disintegrant, and a surfactant (claim 12), wherein the aforementioned components include alcohol, water, dextrin, calcium carbonate, lactose, propylene glycol, liquid paraffin, and saline (claim 13). The nanoparticles comprise at least one of geraniol and oxymatrine (claim 14).
The instant claims are similar and obvious over the reference application’s claims. The reference application’s intended use is for mosquitoes, whereas the claimed invention’s intended use is for red mites. The instant claims recite a pesticide formulation to control chicken red mites, comprising a plurality of nanoparticles, chitosan, geraniol and an essential oil, wherein each nanoparticle is wrapped in chitosan and the pesticide formulation does not translocate to the egg of a chicken (instant claim 1). The chitosan is in a chitosan solution (instant claim 2). Geraniol is at a concentration of 50-4000 ppm (instant claim 3). The essential oil includes oxymatrine, peppermint oil, thyme oil, etc. (instant claim 4). The nanoparticles have a diameter of 20-200 nm (instant claim 5). The nanoparticles are created using a centrifuge (instant claim 6). The formulation further comprises an extender, a wetting agent, a disintegrant, or a surfactant (instant claim 7). The aforementioned components include alcohol, water, dextrin, calcium carbonate lactose, propylene glycol, liquid paraffin, and saline (instant claim 8). The nanoparticles further comprise at least one of geraniol and oxymatrine (instant claim 9). The nanoparticles comprise geraniol at a concentration of 50-4000 ppm (instant claim 10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-13 of copending Application No. 18/484,648 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference application recites a pesticide formulation comprising nanoparticles, chitosan, oxymatrine, wherein the nanoparticles are wrapped in chitosan (claim 1). The formulation is an insecticide, which is interpreted as intended use (claim 2). The formulation is used to control worms, slugs, snails, etc. (claim 3), which is interpreted as intended use. The chitosan is in a chitosan solution (claim 4). The oxymatrine is at a concentration of 50-4000 ppm (claim 5). The nanoparticles have a diameter of 20-200 nm (claim 7). The nanoparticles are created using a centrifuge (claim 8). The formulation is used in an environment, such as a field, lawn, forest, etc., which is interpreted as intended use (claim 9). The formulation comprises at least one of a filler, an extender, a wetting agent, a disintegrant, and a surfactant (claim 10), wherein the aforementioned components include alcohol, water, dextrin, calcium carbonate, lactose, propylene glycol, liquid paraffin, and saline (claim 11). The nanoparticles further comprise geraniol (claim 12). The nanoparticles further comprise rosemary oil, peppermint oil, cottonseed oil, cinnamon oil, or neem oil (claim 13).
The instant claims are similar and obvious over the reference application’s claims. The reference application’s intended use is for slugs, snails, worms, etc., whereas the claimed invention’s intended use is for red mites. The instant claims recite a pesticide formulation to control chicken red mites, comprising a plurality of nanoparticles, chitosan, geraniol and an essential oil, wherein each nanoparticle is wrapped in chitosan and the pesticide formulation does not translocate to the egg of a chicken (instant claim 1). The chitosan is in a chitosan solution (instant claim 2). Geraniol is at a concentration of 50-4000 ppm (instant claim 3). The essential oil includes oxymatrine, peppermint oil, thyme oil, etc. (instant claim 4). The nanoparticles have a diameter of 20-200 nm (instant claim 5). The nanoparticles are created using a centrifuge (instant claim 6). The formulation further comprises an extender, a wetting agent, a disintegrant, or a surfactant (instant claim 7). The aforementioned components include alcohol, water, dextrin, calcium carbonate lactose, propylene glycol, liquid paraffin, and saline (instant claim 8). The nanoparticles further comprise at least one of geraniol and oxymatrine (instant claim 9). The nanoparticles comprise geraniol at a concentration of 50-4000 ppm (instant claim 10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-16 of copending Application No. 18/484,686 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference application recites a pesticide formulation comprising nanoparticles, chitosan, rosemary oil, peppermint oil, and cottonseed oil, wherein the nanoparticles are wrapped in chitosan (claim 1). The formulation is an insecticide, which is interpreted as intended use (claim 2). The formulation is used to control mites, flies, ants, slugs, etc. (claim 3), which is interpreted as intended use. The formulation is a fungicide (claim 4) and used to control scabs, cankers, leaf spot, etc. (claim 5), which are both interpreted as intended use. The chitosan is in a chitosan solution (claim 6). The rosemary oil, peppermint oil, and cottonseed oil are at a concentration of 50-4000 ppm (claim 7). The nanoparticles further comprise spearmint oil (claim 8). The nanoparticles have a diameter of 20-200 nm (claim 10). The nanoparticles are created using a centrifuge (claim 11). The formulation is used in an environment, such as a field, lawn, forest, etc., which is interpreted as intended use (claim 12). The formulation comprises at least one of a filler, an extender, a wetting agent, a disintegrant, and a surfactant (claim 13), wherein the aforementioned components include alcohol, water, dextrin, calcium carbonate, lactose, propylene glycol, liquid paraffin, and saline (claim 14). The nanoparticles further comprise geraniol and oxymatrine (claim 15). The nanoparticles further comprise garlic oil, thyme oil, etc. (claim 16).
The instant claims are similar and obvious over the reference application’s claims. The reference application’s intended use is for flies, ants, mites, etc., whereas the claimed invention’s intended use is for red mites. The instant claims recite a pesticide formulation to control chicken red mites, comprising a plurality of nanoparticles, chitosan, geraniol and an essential oil, wherein each nanoparticle is wrapped in chitosan and the pesticide formulation does not translocate to the egg of a chicken (instant claim 1). The chitosan is in a chitosan solution (instant claim 2). Geraniol is at a concentration of 50-4000 ppm (instant claim 3). The essential oil includes oxymatrine, peppermint oil, thyme oil, spearmint oil, etc. (instant claim 4). The nanoparticles have a diameter of 20-200 nm (instant claim 5). The nanoparticles are created using a centrifuge (instant claim 6). The formulation further comprises an extender, a wetting agent, a disintegrant, or a surfactant (instant claim 7). The aforementioned components include alcohol, water, dextrin, calcium carbonate lactose, propylene glycol, liquid paraffin, and saline (instant claim 8). The nanoparticles further comprise at least one of geraniol and oxymatrine (instant claim 9). The nanoparticles comprise geraniol at a concentration of 50-4000 ppm (instant claim 10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-14 of copending Application No. 18/484,427 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference application recites a pesticide formulation comprising nanoparticles, chitosan, garlic oil, clove oil, and thyme oil, wherein the nanoparticles are wrapped in chitosan (claim 1). The formulation is a fungicide or nematicide, which is interpreted as intended use (claim 2). The formulation is used to control root-knot nematodes, cyst nematodes, etc. (claim 3), which is interpreted as intended use. The chitosan is in a chitosan solution (claim 4). The garlic oil, clove oil, and thyme oil are at a concentration of 50-4000 ppm (claim 5). The nanoparticles further comprise spearmint oil (claim 6). The nanoparticles have a diameter of 20-200 nm (claim 8). The nanoparticles are created using a centrifuge (claim 9). The formulation is used in an environment, such as a field, lawn, forest, etc., which is interpreted as intended use (claim 10). The formulation comprises at least one of a filler, an extender, a wetting agent, a disintegrant, and a surfactant (claim 11), wherein the aforementioned components include alcohol, water, dextrin, calcium carbonate, lactose, propylene glycol, liquid paraffin, and saline (claim 12). The nanoparticles further comprise geraniol and oxymatrine (claim 13). The nanoparticles further comprise rosemary oil, peppermint oil, cottonseed oil, and cinnamon oil (claim 14).
The instant claims are similar and obvious over the reference application’s claims. The reference application’s intended use is for nematodes, whereas the claimed invention’s intended use is for red mites. The instant claims recite a pesticide formulation to control chicken red mites, comprising a plurality of nanoparticles, chitosan, geraniol and an essential oil, wherein each nanoparticle is wrapped in chitosan and the pesticide formulation does not translocate to the egg of a chicken (instant claim 1). The chitosan is in a chitosan solution (instant claim 2). Geraniol is at a concentration of 50-4000 ppm (instant claim 3). The essential oil includes oxymatrine, peppermint oil, thyme oil, spearmint oil, etc. (instant claim 4). The nanoparticles have a diameter of 20-200 nm (instant claim 5). The nanoparticles are created using a centrifuge (instant claim 6). The formulation further comprises an extender, a wetting agent, a disintegrant, or a surfactant (instant claim 7). The aforementioned components include alcohol, water, dextrin, calcium carbonate lactose, propylene glycol, liquid paraffin, and saline (instant claim 8). The nanoparticles further comprise at least one of geraniol and oxymatrine (instant claim 9). The nanoparticles comprise geraniol at a concentration of 50-4000 ppm (instant claim 10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 30 July 2026 have been fully considered but they are not persuasive.
The Applicant argues that Shakeel does not teach the amended limitations in claim 1 (Remarks, pg. 5).
Applicant’s argument is not found persuasive. Regarding Applicant’s amendment to claim 1, the limitation of the chitosan layer “configured to degrade according to time, pH, polarity” is interpreted as a functional limitation of the chitosan layer and is given minimal patentable weight. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding the limitation of at least one chitosan encapsulation layer, since Shakeel does not specifically teach more than one layer of chitosan to encapsulate the nanoparticles in claim 1, it would have been obvious to a skilled artisan to include multiple layers of coating on the nanoparticle composition in Shakeel with a reasonable expectation of success. In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04(VI)(B).
A skilled artisan would have been led to combine the teachings and improve Shakeel’s nanoparticle composition because Alkekhia teaches several benefits, such as controlled drug delivery, when multiple layers of coatings are used on nanoparticles. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
The Applicant argues that the rejection required reconstruction based on impermissible hindsight (Remarks, pg. 5).
Applicant’s argument is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The Applicant argues that Shakeel does not suggest combining the limitations in claim 1 to arrive at the claimed invention (Remarks, pg. 6).
Applicant’s argument is not found persuasive. Regarding claim 1, Shakeel teaches a pesticidal composition (para. 98) that may comprise geraniol (para. 9) and an essential oil (para. 10), such as a botanical essential oil/active ingredient (para. 56), within minicells (abs; entire teaching), which are membrane-encapsulated biological nanoparticles (para. 93). The suspension comprising 0.01 to 5,000 mg of minicells per mL (para. 212) is interpreted as a “plurality of nanoparticles.” The minicell comprising the active agents may be coated in chitosan (para. 198). The composition may be used on chickens (para. 42), where the compositions may provide benefits for egg shell thickness (para. 130), which is understood to mean a chicken with an egg. The composition is used as a pesticide to target mites (para. 40). The limitation of “a pesticide formulation used to control chicken red mites on a chicken, the chicken containing an egg” is interpreted as intended use and is given minimal patentable weight. See MPEP 2111.02(II). The minicell delivering the active agents to a target (para. 202) and also providing benefits for egg shell thickness (para. 130) is interpreted as addressing a pesticide formulation that does not translocate to the egg. Additionally, the limitation of “the pesticide formulation does not translocate to the egg inside the chicken” is interpreted as a functional limitation of the formulation. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding Applicant’s amendment to claim 1, the limitation of the chitosan layer “configured to degrade according to time, pH, polarity” is interpreted as a functional limitation of the chitosan layer and is given minimal patentable weight. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
Regarding the multilayer chitosan encapsulation limitation, since Shakeel does not specifically teach more than one layer of chitosan to encapsulate the nanoparticles in claim 1, it would have been obvious to a skilled artisan to include multiple layers of coating on the nanoparticle composition in Shakeel with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings and improve Shakeel’s nanoparticle composition because Alkekhia teaches several benefits, such as controlled drug delivery, when multiple layers of coatings are used on nanoparticles. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
In regards to selecting the combination of ingredients and layers recited in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
The Double Patenting rejections (see above) are maintained because the Applicant has not responded to the rejections.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
Prosecution Insights