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 with traverse of Group I, claims 14-27 in the reply filed on 12/01/2025 is acknowledged. The traversal is on the ground(s) that Applicant submits that all claims have unity of invention under the 37 CFR 1.475(b), national-stage application, because the claims of group I a method and the claims of group II recite a process of using said product. This is not found persuasive because the claims of Group I are drawn to a method rather than to a product. The method of Group II requires specific formulas that are not required by the method of Group I or the computer-readable comprising instructions of Group III. The invention of Group III requires a computer-readable medium and computer instructions that are not required by Group I or II. Applicant also argues that Grosso et al do not teach determining a first series from a basic ploidy level tipping point T corresponding to an inhibition to go to higher ploidy levels, and determining a second series from tipping point T to a highest ploidy level for the plant system or the sample. This is not found persuasive because Grosso et al teach exposing a plant to a treatment compound; and determining the toxicity effect or growth promotion effect based on the ploidy level obtained at different time points (different series of ploidy level) after tipping. The ploidy level is analyzed using flow cytometry as claimed in Applicant’s claim 24. See the 103 art rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-29 are pending.
Claims 28-29, are withdrawn from consideration as being directed to the non-elected invention.
Claims 14-27 are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
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 21 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.
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 14 recites the broad recitation “Arabidopsis thaliana or Dianthus caryophyllus, and the claim also recites “preferably Arabidopsis thaliana” which is the narrower statement of the range/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. Applicant may overcome the rejection by presenting a dependent claim that sets forth the narrower or preferred plant species.
Note: the specification defines “plant system” as “a plant”.
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.
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.
Claims 14-25 are rejected under 35 U.S.C. 103 as being unpatentable over each of Grosso et al (Plant Cell, Tissue and Organ culture (2017)132(1):57-70; Applicant’s IDS) and Silalahi et al (Earth and Environmental and Food Security (2020) 454:012161) in view of each Yu et al (Theor Appl Genet (2009) 118: 1107-1119) and Nimura et al (Breeding Science (2006)56:303-306).
The claims are drawn to a method for determining a toxicity effect or a growth promotion effect of a treatment or a compound including a carbonized material, on a plant system or parts thereof comprising at least one cell having a ploidy that is provided to change on exposure to the treatment or the compound , the method comprising: exposing the plant system or parts thereof to the treatment or the compound to obtain an exposed system, wherein exposing the plant system or parts thereof to the treatment or the compound comprises applying the treatment or the compound to a growth matrix of the plant system or parts thereof; and determining the toxicity effect or the growth promotion effect based on: a first series of one or more ploidy levels of nuclei in a sample of the exposed system, the first series being determined from a basic ploidy level up to and including a ploidy level tipping point T corresponding to an arrest/inhibition toward higher ploidy levels for the sample; and a second series of one or more ploidy levels of nuclei in the sample, the second series being determined from and excluding the ploidy level tipping point T to a highest ploidy level observed for the plant system; said method, wherein determining the toxicity or the growth promotion effect is based on one or more of a defence endoreplication index or a growth endoreplication index; the defence endoreplication index is determined in accordance with the first series; and the growth endoreplication index is determined in accordance with the second series; wherein determining the toxicity effect or the growth promotion effect comprises: determining the toxicity effect from the first series or from the defence endoreplication index; and/or determining the growth promotion effect from the second series or from the growth endoreplication index; wherein: the toxicity effect on the plant system is determined by comparing the defence endoreplication index of the plant system with a defence endoreplication index of a control; or the growth promotion effect on the plant system is determined by comparing the growth endoreplication index of the plant system with a growth endoreplication index of a control; wherein the growth matrix is a liquid medium, soil, or a substrate of the plant system, wherein the plant system is Arabidopsis thaliana or Dianthus caryophyllus, wherein exposing the plant system or parts thereof comprises exposing a seedling of the plant system to the treatment or the compound in a microtiter plate , wherein determining the toxicity effect or the growth promotion effect comprises measuring data by flow cytometry.
Grosso et al teach a method of determining the toxicity or growth promotion effect of a treatment or a compound on a Dendrobium plant by exposing the plant to the treatment or compound; analyzing the level of ploidy at different time points after tipping (different series of ploidy level); and determining the growth promotion or toxicity based on the ploidy level obtained at different time points after tipping. At page 58, Grosso et al state “[c]hromosome doubling is an acknowledged mechanism to obtain different ploidy levels in plants, and it is usually achieved by chemical treatments using anti-microtubule agents such as colchicine or oryzaline…) and that a proper method for in vitro polyploidization can be developed for any target plant species. Grosso et al teach culturing explants in a liquid medium supplemented with colchicine at concentrations of 0.00% (control), 0.025%.0.050% and 0.075% with an incubation period of 3, 10 and 21 days, for polyploid induction; ploidy induction level/efficiency was determined using flow cytometry (FCM) and synthetic index (paragraph bridging columns 1 and 2 of page 59). See Fig. 1. The trend of endopolyploidization on embryos like bodies (PLBs) during the 28 days culturing in the liquid medium with a cycle value obtained at four time points are shown on Fig. 2. Grosso et al teach obtaining tetraploid plants after transferring the PLBs obtained from the cultured explants (diploid) to an anti-mitotic solid growth medium. Grosso et al also teach conducting ploidy analysis using flow cytometry on control PBLs at 3, 10 and 28 days and on fresh leaves at 28 days after polyploidization treatment. Fig. 3 and results demonstrated that PLBs treated for 3 days at all concentrations showed higher growth rates than the control, and death of all PLBs after 21 days independent from the concentrations used. Table 1 shows flow cytometry analysis, polyploid recovery and cell cycle value index. Grosso et al teach that polyploid analysis via flow cytometry allows rapid and reliable way to measure DNA content (2C, 4C, 8C, 16C, 32C as shown in Fig 4) and the analysis of a large number of explants in a short period of time. Grosso et al also teach the importance of polyploidization of plants including it provide plants with a new genotype and higher yield as compared to its diploid original plants.
Silalahi et al teach a method of determining the growth/toxicity of two varieties of tomato comprising applying several concentrations 90, 30, 60, 90, and 120 uM of oryzalin on the seeds of two tomato varieties to induce tetraploidy; sowing the treated and untreated seeds in a tray with liquid medium; transferring the seedlings having two to four leaves to soil medium; and observing plant height, leaf numbers and stem diameter for 30 days (Tables 1-3). Figs. 1 and 2 show higher concentrations of oryzalin caused disruption of plant growth (reduction of both plant length and leaf number) which show the oryzalin became toxic to the plant compared to untreated plants. Silalahi et al state that the decreased growth rate of polyploids was caused by the reduced rate of cell division.
Each of Grosso et al and Silalahi et al do not teach the Arabidopsis thaliana or Dianthus Caryophyllus plant system of claims 21 or 22.
Yu et al teach a method of generating tetraploid Arabidopsis thaliana plants by exposing several concentrations of colchicine to explants in a culture liquid medium for about a week and subsequently planting it on soil, or by placing a drop of colchicine solution on the apex of young seedlings having less than five primary leaves (Table 1). Fig. 1 on page 1110 shows induction, identification and evaluation of polyploids in the Arabidopsis thaliana. Evaluation of Polyploid was conducted using Flow cytometry with leaves from colchicine treated plants. At the paragraph bridging columns 1 and 2 of page 1110, Yu et al teach comparing the peak positions of the 2C, 4C, 8C, 16C and 32C nucleic between diploid and tetraploid whose ploidy was already known, and state “[d]ue to endopolyploidy, flow cytometry measurements from Arabidopsis plant not only exhibit a 2C peak but also further peaks up to 32C. Consequently, plants with a basic ploidy level e.g. tetraploids lack the 2C peak.” Yu et al also teach that seedlings that survived the treatment and displayed polyploid were grown to maturity and harvested; seeds of F1 generation grown to seedlings were evaluated for polyploid by chromosome index as shown on Table 2 and corresponding mature plants were selected for flow cytometry analysis. Fig. 3 shows identification, selection and evaluation of polyploid lines in consecutive generations. Yu et al show that plants with basic ploidy level higher than diploid lacked the 2C peak, and plants with basic polyploid level higher than tetraploid in addition lacked the 4C peak (Fig. 5).
Nimura et al teach a method of inducing polyploid in a Dianthus caryophyllus plants by applying drops of colchicine solution on to the shoot tips of greenhouse grown diploid carnation plants or by treating nodal segments from plants by incubating a colchicine or amiprophos-methyl (AMP) solution; and regenerating tetraploids, one octaploids and 88 mixoploids. Tables 1-2 show effects of different concentrations of colchicine applied to apical meristem on the survival rate and induction of polyploid in a hybrid Dianthus caryophyllus. Fig 3A-3E show the results of the flow cytometry analysis of all plants. The effects include 25% increase in yield of the tetraploid carnation plants.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the method of determining the toxicity or growth promotion effect of a treatment/compound on a desired plant by exposing the plant or part thereof to the treatment compound; analyzing the level of ploidy at different time points after tipping (different series of ploidy level) using flow cytometry; and determining the growth promotion or toxicity based on the ploidy level obtained at different time points after tipping as taught by Grosso et al, and to modify that method by incorporating other plant species including Arabidopsis thaliana and Dianthus caryophyllus, to determine growth and/or toxic effect of the treatment as taught by Grosso et al, given that Arabidopsis thaliana is a model plant and has been successfully applied colchicine treatment to induce polyploidization and that growth and/or toxic effects can be determined as taught by Yu et al, and given that Dianthus caryophyllus is an important ornamental plant and has been successfully applied colchicine to induce polyploidization and that growth and/or toxic effects can be determined as taught by Nimura et al, and given that the Dianthus caryophyllus and the Dendrobium plant taught by Grosso et al are both ornamental plants. One of skill in the art would have been motivated to induce polyploidization in plants including ornamental plants like Dianthus caryophyllus and Dendrobium, a model plant like Arabidopsis thaliana plant, or a crop plant like tomato as taught by Silalahi et al, given that polyploidization of plants creates plants with a new genotype and higher yield as compared to its original plant. One would also have been motivated to develop a protocol for polyploidization of a desired plant given that polyploidization in basic chromosome numbers is major source of quality production and evolution of flowering plants such as ornamental plants as known to an skilled in the art and as shown by the several references listed below under “remarks”. It is well known in the art that polyploidy in ornamental plants provides enlargement of flowers and leaves, intensification of colors, rigid and thicker foliage, and increases in resistance to biotic and abiotic stresses. While the limitations including “determining basic ploidy level” , “ploidy level tipping point T”, and “excluding the ploidy level tipping point T to a highest ploidy level observed for the plant system” are covered in the flow cytometry analysis, these limitations are also taught in Yu et al where it teach comparing the peak positions of the 2C, 4C, 8C, 16C and 32C nucleic between diploid and tetraploid whose ploidy was already known, and that plants with a basic ploidy level e.g. tetraploids lack the 2C peak, and where it states “[d]ue to endopolyploidy, flow cytometry measurements from Arabidopsis plant not only exhibit a 2C peak but also further peaks up to 32C”. Further, the use of a microtiter plant does not constitute unexpected results as it is an obvious choice in the design of the experiment.
Therefore, for all the reasons discussed above, determining the toxicity or the growth promotion effect of a polyploidy inducing treatment or compound on a plant system or parts would not constitute unexpected results, absent evidence to the contrary.
Remarks
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tiwari and Mishari (African Journal of Biotechnology (2012) 11(39):9336-9342) teach effects of colchicine on polyploidization and growth of the ornamental plant species Phlox drummondi . Talebi et al (Caryologia: International Journal of Cytology, Cytosystematics and Cytogenetics (2016), 70(2): 184-193) teach inducing tetraploidy in Anise hyssop plants using different concentrations of colchicine and improved plant size, leaf thickness, flower size, increased cell size and large reproductive and vegetative organs. Wang et al (ACS Sustainable Chemistry & Engineering (2017)5:481-488) teach toxicity evaluations of different biochars on wheat germination and growth. Soudek et al (Journal of Geochemical Exploration (2017) 182:157-165) teach effects of different types of biochar on the toxicity of cadmium, copper and lead to germination of sorghum seeds.
Claims 26 and 27 are deemed free of the prior art of record, given that the prior art does not teach or suggest a polyploidization effects of carbonized material or biochars on plants.
No claim is allowed.
Contact Information
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662