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 Claims
Claims 1-20 are currently pending and are examined on the merits herein.
Priority
The instant application filed 10/23/2023, claims the benefit of U.S. Provisional Application No. 63/475,168, filed 10/21/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/09/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informality: Paragraph [0001] makes cross-reference to U.S. Provisional Application 63/475,168, reciting that such an application was filed on “21 October 2023”. According to the Application data available to the Examiner, it seems that Application 63/475,168 was filed on 21 October 2022, and that Applicant has made a typographical error in reciting “2023”. Appropriate correction is required.
Claim Objections
Claims 1 and 6-7 are objected to because of the following informalities:
Claim 1 recites the word “agrochecmical” which is believed to be a typographical error which should recite “agrochemical”;
Claim 6 recites various agrochemical names in their capitalized form, please remove capitalization;
Claim 7 recites “cellulose nanocrystals” or “cellulose microcrystals” and then abbreviates the limitation for lignin and starch by reciting “micro/nano crystals”. Please amend for consistency (i.e., either write out nanocrystals and microcrystals for each species or use the abbreviation for each species);
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 15-17: The specification describes a composition comprising agrochemical loaded CNC and its preparation. In certain embodiments, the concentration of CNC in organic solvent is 0-100 wt%, and more preferably from about 1.0 to about 20.0 wt% ([00067] of specification). These weight ranges appear to refer to the final composition of the invention, which is generated by the method defined in steps (a)-(e) of instant claim 1. Such a conclusion is supported by the Examples which teach a final step (e) of dispersing the product of step (d) into water to give concentrations ranging from 0.1 wt% to 2 wt% (Examples 1-6 of the instant specification). Example 8 teaches a final amount of CNC in the CS-coated nanocapsules of 0.5 wt% based on a working volume of 10 mL. When the amount of CNC is calculated in each of these examples relative to the weight of the solvent in the dispersion of step (b), as defined in claims 15-16, the instantly claimed percentages are not provided. Rather, the specification only describes amounts of CNC within the claimed numerical ranges when calculated relative to the weight of the solvent in the final dispersion. Further regarding claim 17, none of the examples in the instant specification provide CNC in an amount of 1.0 to 20.0 wt% relative to the organic solvent in step (b). Additionally, none of the examples re-disperse the biomass-based product in an organic solvent following step (d) which removes the organic solvent. As such, the invention as defined in claims 15-17 is not adequately described by the instant specification.
Claim Rejections - 35 USC § 112(b)
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.
1. Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 defines a method for preparing a “biomass-based nano-dispersion” of a hydrophobic agrochemical. The steps include required steps (a)-(d) and optional step (e). The final required step (d) results in “an agrochemical-biomass based product”. Optional step (e) comprises dispersing the above agrochemical-biomass based product from (d) in water. As such, in one embodiment (i.e., wherein step (e) is not performed) the resulting composition is not a dispersion. Thus, the body of the claims do not support the preamble.
Claims 1 recites “at least one organic solvent” in both steps (a) and (b). Claim 1 also recites “removing the organic solvent” in step (d). Claim 2 recites “wherein the at least one organic solvent comprises […]”. It is unclear if the organic solvents of step (a) and (b) are the same or different. Furthermore, because claim 1 does not differentiate between the organic solvents of each step, it is unclear which organic solvent is referred to in step (d) of claim 1 and in claim 2. For the sake of compact prosecution, the at least one organic solvent will be interpreted as being the same in step (a) and step (b).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation of “a polysaccharide”, and the claim also recites “chitosan”, “chitin”, and “cellulose” which are narrower statements of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 13 and 14 recite an “amount of hydrophobic agrochemical […] relative to the weight of the at least one organic solvent solution in step (a)”. It is unclear if “the organic solvent solution in step (a)” is the organic solvent of step (a) alone or if it is the hydrophobic agrochemical and the solvent together.
Claim 16 recites the amount of CNC relative to “the weight of the solvent dispersion in step (b)”. It is unclear to the Examiner if this limitation is a narrower statement of claim 15 which recites CNC relative to the weight of the solvent in the dispersion of step (b), or if the limitation refers to the total weight of the dispersion of step (b).
Claim 17 recites the amount of CNC “relative to the weight of the at least one organic solvent in the dispersion in step (b)”. However, claim 1 defines step (b) as comprising an aqueous solution or at least one organic solvent. There is no claim that explicitly defines the selection of an organic solvent in step (b). Thus, in the embodiment where an aqueous solution is used and no organic solvent is present, the “weight of the at least one organic solvent in the dispersion in step (b)” would be zero. Calculating an amount of CNC relative to zero would result in an undefined percent which is indefinite.
Overall, it is very unclear to the Examiner how the weigh percentages of CNC are being calculated in claims 15-17. As mentioned in the 112(a) rejection above, there are discrepancies between the claim language and the teachings of the instant specification.
The remaining claims are rejected by virtue of their dependency on claim 1.
Claim Interpretation
As discussed above, the claims are unclear and differ from the teachings of the instant specification. For the sake of compact prosecution, the following interpretations have been made to the best of the Examiners abilities:
Claims 13-14 recite the amount of hydrophobic agrochemical relative to the weight of the at least one organic solvent solution in step (a). As best interpreted given the 112(b) issue above, the amount of agrochemical in claims 13-14 will be interpreted as being relative to the weight of the entire solution in step (a), which includes the agrochemical plus the organic solvent.
Claims 15-16 recite the amount of CNC relative to the solvent in step (b). As best interpreted given the 112(a) and 112(b) issues above, the amount of CNC in claims 15-16 will be interpreted as being relative to the weight of the solvent in the final dispersion produced by the method of claim 1.
Claim 17 recites the amount of CNC relative to the at least one organic solvent in the dispersion in step (b). As best interpreted given the 112(a) and 112(b) issues above, the amount of CNC in claim 17 will be interpreted as being relative to the weight of the at least one organic solvent in the dispersion in step (b).
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.
1. Claims 1-11, 13-16, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim, D. S. (2020). Mucoadhesive nanocomposite derived from cellulose nanocrystal and chitosan for the delivery of hydrophobic compounds (thesis). Mucoadhesive Nanocomposite Derived from Cellulose Nanocrystal and Chitosan for the Delivery of Hydrophobic Compounds. University of Waterloo, Waterloo, Ontario (PTO-892), hereinafter Kim, as evidenced by National Center for Biotechnology Information (2025). PubChem Compound Summary for CID 180, Acetone. Retrieved November 18, 2025 (PTO-892), hereinafter NCBI.
Kim discloses the development of a mucoadhesive drug delivery system that can encapsulate poorly water-soluble molecules by using cellulose nanocrystals (CNC) and chitosan (CS) based nanogels prepared via electrostatic gelation (p. 41, para. 3). Emamectin benzoate (EMB), a widely used pesticide was used as a model for hydrophobic drugs (p. 3, para. 2).
Regarding claim 1: CNC-PVP-EMB-CS (CPEC) nanoparticles were synthesized as follows: 1g of CNC and 0.1g of PVP were mixed in 0.8 mL acetone and stirred overnight (p. 42, 3.2.3), which reads on step b. Various amounts of EMB were dissolved in 0.2 mL of acetone (p. 42, 3.2.3), which reads on step a. EMB (0.2 mL) solutions were slowly injected into the CNC/PVP solution (0.8 mL) under sonication for 5 minutes (p. 42, 3.2.3), which reads on step c. Then, the mixtures were dried in the oven at 40 ˚C and re-dispersed in milli-Q water (200 mL) (p. 42, 3.2.3), reading on steps d and e.
Regarding claim 2: Kim teaches acetone as the organic solvent in the above method.
Regarding claim 3: The synthesis of the CPEC nanoparticles further includes the step of CS encapsulation, wherein various concentrations of CS were prepared in 1 % acetic acid solution and slowly injected into the CPE (CNC-PVP-EMB) solutions (p. 42, 3.2.3). The resulting CPEC nanoparticles therefore comprise chitosan (CS) and cellulose as the biomass-based particles.
Regarding claim 4: Kim utilizes heat as the method of drying the organic mixture.
Regarding claims 5 and 6: The agrochemical used in the CPEC nanoparticles is emamectin benzoate (EMB), which is a commercially available pesticide.
Regarding claim 7: The CPEC nanoparticles comprises cellulose nanocrystals.
Regarding claim 8: The CPEC nanoparticles comprise a combination of cellulose nanocrystals (CNC) and chitosan (CS).
Regarding claim 9: The optimized mass ratio (CNC:CS w/w) in the CPEC nanoparticles was 10:1 (i.e., 1:10 CS to CNC) (p. 68, 3.4). Additionally, table 3 shows mass ratios of CS:CNC ranging from 1:1.3 to 1:50, all of which fall within the claimed range (i.e., 1:1 to 1:50, CS:CNC).
Regarding claim 10: The particle size of the CPEC nanocomposites ranged from 200 nm to ~2 µm, depending on the mass ratio of CNC to CS. Additionally, the mucoadhesive properties of CPEC
nanoparticle were demonstrated using a zebra fish, and the nanoparticles were successfully
bound to zebra fish mucus and remained on the fish skin for several days (p. 68, 3.4).
Regarding claim 11: The CPEC nanocomposite comprises PVP (i.e., polyvinylpyrrolidone).
Regarding claims 13 and 14: Kim further teaches the synthesis of CPECg nanoparticles, wherein the chitosan is GTMAC-modified chitosan (Gsh) (p. 73, 4.2.2). The CPECg nanoparticles were synthesized in an identical method as above except modified chitosan was used and the amount of EMB dissolved in 0.2 mL acetone (i.e., step a) ranged from 10 to 200 mg (p. 73, 4.2.2). As interpreted above, the weight of the at least one organic solvent solution in step a would be the sum of EMB and the acetone used to dissolve it. Given that acetone has a density of 0.791 g/mL as evidenced by NCBI, 0.2 mL would be equal to 0.1582 g or 158.2 mg. Therefore, when 10 mg of EMB is used, EMB is provided in an amount of 5.9 wt% relative to the weight of the organic solvent solution of step a (i.e., 10 mg ÷ (10 mg + 158.2 mg) *100). An amount of 5.9% falls within the range of both claims 13 and 14.
Regarding claims 15-16: In both methods describe above (i.e., CPEC and CPECg), 1g of CNCs are added in step (b), the initial solvents are removed in a drying process and the CNC/PVP/EMB mixture is re-dispersed in 200 mL of water (p. 42, 3.2.3; p. 73, 4.2.2). The resulting dispersion therefore comprises CNC at an amount of 0.5 wt% relative to the weight of the solvent in the final dispersion as best interpreted above (i.e., 1 g ÷ 200 g *100). Table 3 also teaches 0.5 wt% of CNC in CPE solutions prior to injecting the chitosan solution for coating (p. 55-56), which also reads on the amount of CNC as best interpreted in claims 15-16.
Regarding claim 18: The drug loading and encapsulation efficiency of CPEC were 11.6 and 65.6 %, respectively (p. 68, para. 1). A drug loading of 11.6% reads on an amount of 5 to 20 wt% of agrochemical relative to the total weight of the biomass based product, as instantly claimed.
Regarding claims 19 and 20, since the methods of claims 10 and 11 are taught by Kim above, the products produced from such methods are necessarily taught as well.
Claims 1-7, 13-14, 15-16*, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elabasy, A., et al. (2019). Synthesis, Characterization, and Pesticidal Activity of Emamectin Benzoate Nanoformulations against Phenacoccus solenopsis Tinsley (Hemiptera: Pseudococcidae). Molecules, 24(15), 2801 (PTO-892), hereinafter Elabasy, as evidenced by Fisher Scientific. (2025). Methanol. Lab Equipment and Lab Supplies (PTO-892), hereinafter Fisher Scientific.
Elabasy discloses the preparation of a novel nanoformulation (NF) based on nano-delivery systems for emamectin benzoate (EMB) by loading it on cellulose nanocrystals (CNCs) as carriers through a freeze-drying method (abstract).
Regarding claim 1: 1.0 g of CNCs was dispersed in 250 mL of ddH2O and the CNCs were sonicated for 30 min to ensure that CNCs were entirely dispersed (p. 10-11, 3.2.1), which reads on step b. Then, 1.42 g of EMB technical grade (equivalent to 1 g EMB active ingredient) was dissolved in 20 mL of methanol (p. 10-11, 3.2.1), which reads on step a. The EMB solution was added dropwise into the dispersed CNCs and continuously stirred by the magnetic stirrer at a speed of 800 rpm for two hours at 25 °C (p. 10-11, 3.2.1), which reads on step c. After the EMB was lodged entirely onto the surface of CNCs, the mixture was freeze-dried for 24 h to obtain EMB + CNCs powder (p. 10-11, 3.2.1), which reads on step d. Since step e is optional, the method of Elabasy reads fully on the method of claim 1.
Regarding claim 2: Elabasy teaches methanol as the organic solvent in the above method.
Regarding claim 3: The above method utilizes cellulose as biomass-based particles.
Regarding claim 4: Elabasy teaches freeze-drying for drying the organic mixture.
Regarding claims 5 and 6: The agrochemical used is emamectin benzoate (EMB), which is a commercially available pesticide.
Regarding claim 7: The above method utilizes cellulose nanocrystals as biomass-based particles.
Regarding claims 13 and 14: The 20 mL of methanol used to dissolve EMB in the above method is equivalent to 15.82 g, given that methanol has a density of 0.791 g/mL as evidenced by Fisher Scientific. As such, 1 gram of EMB dissolved in 15.82 g of methanol provides EMB at an amount of 5.9 wt% relative to the weight of the organic solvent solution of step (a) (i.e., 1 g ÷ (1 g + 15.82 g)*100), as best interpreted above. An amount of 5.9% falls within the ranges of claims 13 and 14.
*Regarding claims 15-16: The final product of Elabasy is a powder, not a dispersion. Thus, the teachings of Elabasy cannot teach an amount of CNC relative to the solvent in a final dispersion, as best interpreted given the 112(a) and 112(b) issues above. However, in the case that such a claim interpretation is wrong and the claim is in fact drawn to the amount of CNC relative to the amount of solvent in the dispersion of step (b) only, the 1 g of CNC in 250 mL of ddH2O taught by Elabasy above provides CNC at an amount of 0.4 wt% (i.e., 1 g ÷ 250 g*100), which falls within the claimed ranges.
Regarding claim 18: Elabasy teaches a loading efficiency for EMB of approximately 15.04% w/w for CNCs nanoformulations (p. 13, conclusion). A loading efficiency of 15.04% reads on an amount of 5 to 20 wt% of agrochemical relative to the total weight of the biomass based product as instantly claimed.
Alternatively, if Applicants persuasively argue against the claim interpretations and rejection of claims under anticipation, cited above, the following rejection applies.
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.
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.
1. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, D. S. (2020). Mucoadhesive nanocomposite derived from cellulose nanocrystal and chitosan for the delivery of hydrophobic compounds (thesis). Mucoadhesive Nanocomposite Derived from Cellulose Nanocrystal and Chitosan for the Delivery of Hydrophobic Compounds. University of Waterloo, Waterloo, Ontario as evidenced by the National Center for Biotechnology Information (2025). PubChem Compound Summary for CID 180, Acetone. Retrieved November 18, 2025 (PTO-892), hereinafter NCBI.
The teachings of Kim are discussed above.
Regarding claim 12: Kim further teaches functionalizing the chitosan surface with catechol groups to induce covalent bonding with mucin (p. 4, 1.3). CS-cat (chitosan functionalized with catechol groups) and mucin interactions were determined with a turbidity measurement of a CS-cat and mucin mixture. When mucin was mixed with CS-cat, aggregates were formed, thereby confirming the interaction between CS-cat and mucin. As shown in figure 5-18, the binding interaction between CS-cat and mucin was enhanced compared to pure CS solution (p. 109, 5.3.7). Kim speculates that in the future, turbidity measurement between CNC/CS nanocomposite and mucin protein can be done to elucidate the interaction between the nanocomposites and the mucus membrane (p. 113, Future plans).
The teachings of Kim differ from that of the instantly claimed invention in that Kim does not explicitly teach the biomass-based particles to comprise mucin, as recited in claim 12, nor wherein the amount of CNC is between 1.0 and 20.0 wt% relative to the weight of the at least one organic solvent in the dispersion in step (b), as best interpreted for claim 17 above.
Additionally, in the case where the claim interpretation for claims 15-16 is incorrect, the teachings of Kim differ from that of the instantly claimed invention in that Kim does not teach the amount of CNC as defined in claims 15-16.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use chitosan functionalized with catechol groups in the CNC/EMB/CS nanocomposites since the catechol groups provide increased mucoadhesion as taught by Kim. It would have been further obvious to mix CNC/EMB/CS-catechol nanocomposites with mucin in order to elucidate the interactions between the nanocomposites and the mucus membrane as taught by Kim. One of ordinary skill in the art would have been motivated to make such modifications in order to increase and define the mucoadhesive properties of the CNS/EMB/CS nanocomposites. Such modifications would result in mucin being incorporated into the biomass-based particles as instantly defined in claim 12, since Kim teaches that CS-cat and mucin form aggregates when mixed.
In the case where the amounts of CNC taught by Kim do not fall within the instantly claimed ranges of claims 15-17, it is well within the abilities of an ordinary artisan to optimize the amount of CNC provided in the method depending on the desired stability and encapsulation of the agrochemical in the generated product. As such, one of ordinary skill in the art would have arrived at the instantly claimed ranges of claims 15-17 through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since Kim 1) encourages further optimization and investigation into the nanocomposite-mucin interactions and 2) the optimization of amounts is well within the skills of an ordinary artisan.
Conclusion
No claims are allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616