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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Information Disclosure Statement
The Information Disclosure Statements filed on 4/14/2026 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
The amendment (as “Amendment Submitted”) filed 4/14/2026 has been entered.
Claims 2, 5-7, 9-10, 16 had/have been canceled.
Claims 1, 13-15, 17-19 have been amended.
In summary, claims 1, 3-4, 8, 11-15, 17-19 are pending and examined in this office action.
Claim Rejections - 35 USC § 112
Scope of Enablement
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.
Claims 1, 3-4, 8, 11, 13-15, 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification,
while being enabling for a composition or a method of delivering the claimed specific nanocarrier at a concentration equal or below 1 g/L, or the claimed specific nanomaterial conjugate at a concentration equal or below 1 g/L, across plant cell walls into interiors of plant cells, in a safe and non-toxic manner,
does not reasonably provide enablement for the composition or the method of using the nanocarrier or the nanomaterial conjugate at a concentration above 1 g/L without causing toxicity to the plant cells or to the environment where the plants grow.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Claim 1 is drawn a specific nanomaterial conjugate comprising:
a nanocarrier comprising amine-functionalized cellulose nanocrystal (CNC); and
the active agent directly covalently linked to a surface of the amine functionalized CNC,
wherein the nanocarrier is configured to transport the covalently linked active agent across cell walls into cell interiors of plant cells of the plant; and
wherein the active agent comprises an agrochemical, a polynucleotide, a polypeptide, or a combination thereof,
for delivering an active agent to a plant.
Notes:
(1) the nanocarrier or the nanomaterial conjugate is delivered to cell interior; and
(2) the nanocarrier or the nanomaterial conjugate is at unlimited amount(s) or concentration(s).
Claim 13 is drawn to a method comprising
introducing an amount of a specific nanomaterial conjugate (comprising a nanocarrier comprising amine functionalized cellulose nanocrystal (CNC) and the active agent directly covalently linked to a surface of the amine-functionalized CNC the nanocarrier) to a medium to form a mixture thereof; and
maintaining the mixture at a temperature for a period of time to allow sufficient interaction of the plant cells with the nanomaterial conjugate,
wherein the nanocarrier is configured to transport the covalently linked active agent across the cell walls into cell interiors of the plant cells;
wherein the active agent is an agrochemical, a polynucleotide, a polypeptide, or a combination thereof; and
wherein the nanomaterial conjugate is applied at a concentration in a range of 0.1
mg/L to 100g/L,
for delivering an active agent across cell walls of plant cells.
(1) the nanocarrier or the nanomaterial conjugate is put into a medium (for example, field or water);
(2) the nanocarrier or the nanomaterial conjugate is delivered to cell interior; and
(3) the nanocarrier or the nanomaterial conjugate is at unlimited amount(s) and at a concentration up to 100g/L.
The specification provides examples of treating tomato seeds with the specific CNC at a concentration of 0, 10, 50, 100, 500, and 1000 mg/L, and demonstrated that the seeds are undamaged and regenerated (page 3, last para; Figure 1a, upper panel).
The specification provides examples of using the specific CNC at a concentration of 1 g/L (1000 mg/L) in a hydroponics system comprising different tomato plant tissues (leaves, flowers and fruits), and demonstrated that the plant cells are undamaged and regenerated (page 3, last para; page 4, 1st para; Figure 1C-1G).
The specification also provides examples of using the specific CNC at concentrations of 50 mg/L and 1 g/L to treat tomato plant cells for 3 weeks, and demonstrated that the plant cells are undamaged (page 4, 2nd para; Figure 2A-2C).
Thus, the specific reasonably demonstrated that and provides guidance that delivering into or treating plant cells with the claimed specific nanocarrier or CNC at a concentration equal or below 1 g/L, does not cause observed toxicity.
However, the specification does not provide any example not to mention convincing example, to serve as guidance, of using the specific nanocarrier or CNC at a concentration above 1 g/L, without causing toxicity to plant cells or to environment.
In prior art, the knowledge of using the claimed specific nanocarrier or CNC as a mean to deliver DNA into plants, is still limited.
According to the applicant’s own recent publication (Vinzant et al, Cellulose Nanocrystals are a Renewable and Biocompatible Nanocarrier of Agrochemicals Directly to Plant Cells. Adv. Sustainable Syst.p1-13, 2024), it is widely assumed CNC would be highly biocompatible and low in toxicity. However, nanoscale materials can possess novel properties and affect exposed organisms in unexpected ways. For example, we previously reported that nanoscale carbon-based materials can cause biological effects in plants. Therefore, before CNC can be safely applied to plants, it is necessary to comprehensively characterize the impact of the material on plants at a physiological and molecular level (p5, left col, 2nd para).
Vinzant et al teach that tomato seeds were treated with CNC concentrations (10, 50, 100, and 500 mg L−1), and that 1, 20, 40, 60, 80, and 100 g L−1 Stock CNC was diluted with ddH2O and sonicated to homogeneity before use (p8, right col, last para).
Thus, the CNC concentrations of 1, 20, 40, 60, 80, and 100 g/L in fig 1A, lower panel of the instant specification, likely are stock concentration before dilution.
The applicant is the first one to use the claimed specific CNC to successfully treat plant cells and using the claimed specific CNC to deliver agrochemicals to plant cells. No prior art teaches not to mention demonstrated such treatment or delivering.
MPEP 2164 provides the Enablement Requirement. MPEP section 2164.01 states “Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention”
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
Therefore, given the claim breadth, lack of guidance in the specification, insufficient working examples in the instant specification, unpredictability in the prior art, undue experimentation would have been required by one skilled in the art to make and use the invention as broadly claimed.
As analyzed above, according to the applicant, before CNC can be safely applied to plants, it is necessary to comprehensively characterize the impact of the material on plants at a physiological and molecular level.
In this case, undue experimentation would have been required by one skilled in the art to make and use the composition or the method of using the nanocarrier or the nanomaterial conjugate at a concentration above 1 g/L without causing toxicity to the plant cells or to the environment where the plants grow.
Note: Claims 12 and 19 recite nanocarrier or nanomaterial conjugate is applied at a concentration below or equal to 500 mg/L, thus, are excluded from the rejection.
Other dependent claims do not cure the deficiency, thus, are included.
Remarks
The applicant is the first one to use the claimed specific CNC to successfully treat plant cells and using the claimed specific CNC to deliver agrochemicals to plant cells. No prior art teaches not to mention demonstrated such treatment or delivering.
In addition, the specification provides examples demonstrating successfully treating tomato tissues, seeds, leaves, flowers and fruits, with the claimed specific CNC at concentration below or equal to 1 g/L, for cell regeneration and more (pages last, para; page 4, 1st and 2nd paras; figures 1-5).
No art rejection is made.
Response to Arguments
Claims have been significantly amended. The subject matters of the “amine-functionalized cellulose nanocrystal (CNC)”, the “the active agent directly covalently linked to a surface of the amine functionalized CNC”, and the “the nanocarrier is configured to transport the covalently linked active agent across cell walls into cell interiors of plant cells of the plant”, were never presented in any of the previous claims.
Thus, all of the previous rejections are withdrawn. The arguments to the previous rejections are no longer applicable.
The instant rejections are newly made in view of the applicant’s amendments.
Conclusion
Claims 1, 3-4, 8, 11, 13-15, 17-18 are rejected.
Claims 12 and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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/Wayne Zhong/
Primary Examiner, Art Unit 1662
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