Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Previous Rejections
Applicants' arguments, filed 03/02/26 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (Carbohydrate polymers 101 (2014) 1061-1067) in view of Richter et al. (CS196329 (B2); translation of record) and further in view of Pang et al. (CN 104326836A; translation of record).
Kumar et al. discloses pesticide loaded sodium alginate nanoparticles, see title. Kumar et al. teaches with the help of nanotechnology, controlled release of agrochemicals, site targeted delivery of various macromolecules desired for improved plant disease resistance, enhanced plant growth and efficient nutrition utilization can be easily done. Nanoencapsulation has an advantage of safer handling and more efficient use of pesticides with less exposure to environment that guarantees eco-protection. In plant entomology, nanotechnology targets specific agricultural problems in plant pests interaction and provide new ways for crop protection.
Kumar et al. does not teach nanoparticles comprising sodium dithionite.
Kumar et al. also does not teach use of potassium nitrite.
Richter et al. discloses plant growth regulator which can be used in agriculture, see title and summary of the invention. The reference teaches plant growth regulators which are also used in particular to promote crop growth in agriculture, see summary of invention. The reference teaches sodium dithionite or potassium dithionite wherein they are characterized as a plant growth regulator salts and used, see claim 2. The reference teaches use of carriers, fillers, diluents and/or other auxiliaries, see claim 2. The amount of sodium sulfate which has also been characterized as plant growth regulator in addition to dithionites, is added to the formulation in an amount of 0.01 wt.=1000ppm, see claim 2 and also [0015]. The amount of active ingredient in general as plant growth regulator is disclosed as ranging from 0.001% to 99.5%, see claim 2. Richter also teaches use of the actives as granules or in powdered form, see under summary of invention, 15th paragraph.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized sodium dithionite or potassium dithionite as agricultural active ingredients and have encapsulated the same within sodium alginate nanoparticles of Kumar et al. One of ordinary skill would have been motivated to do so because Kumar et al teaches that with the help of nanotechnology, controlled release of agrochemicals, site targeted delivery of various macromolecules desired for improved plant disease resistance, enhanced plant growth and efficient nutrition utilization can be easily done and Richter et al. teaches that sodium and potassium dithionites act as plant growth regulators and are also used in particular to promote crop growth in agriculture, see summary of invention, paragraph [0041].
The references do not teach use of potassium nitrite.
Pang et al. teaches fertilizer compositions comprising potassium nitrite as a nutrient salt (Claim 7).
It would have been obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to have utilized potassium nitrite into the alginate nanoparticle of Kumar et al. as modified by Richter et al. comprising plant growth regulators such as sulfates and nitrates along with potassium nitrite. One of ordinary skill would have been motivated to do so because Kumar et al teaches that with the help of nanotechnology, controlled release of agrochemicals, site targeted delivery of various macromolecules desired for improved plant disease resistance, enhanced plant growth and efficient nutrition utilization can be easily done and Pang et al. teaches utilization of potassium nitrite as a suitable fertilizer nutrient salt. Thus, the expected result would be formation of an alginate nanoparticle comprising sodium dithionite as plant growth regulator and sodium nitrite as a plant nutrient helping in promoting enhanced plant growth and providing nutrient as well. Since Richter teaches the generic amounts of sodium dithionite (ranging from 0.001% to 99.5%) and Pang teaches potassium nitrite as a nutrient, it would be within skill of an artisan to have optimized the amount for optimum growth of plant by performing experimental manipulations.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (Carbohydrate polymers 101 (2014) 1061-1067) in view of Richter et al. (CS196329 (B2), translation provided) and further in view of Pang et al. (CN 104326836A, translation provided) and Chen et al. (US PG Pub. 2022/0154030A1).
The references discussed above do not teach use of a coating agent such as maltodextrin.
Chen et al. teaches agricultural coatings, see [0002]. Protection of seeds from pests in and around the soil during early stages of plant growth was of concern, see [0003]. The seed coatings promote retention of active ingredients or agricultural compounds in the soil, such that they are readily available to the plants and vegetations. In an effort to make such seeds, the seeds are coated with one or more layers of coatings where each layer provides one or more benefits to fertilizers, herbicides, pesticides and the like, see [0006-0008]. Chen et al. teaches seed coatings wherein the seeds coatings can be maltodextrin and an active ingredient can be plant growth regulator, see [0016], [0041] and [0044].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the coating of maltodextrin over the nanoparticle comprising sodium dithionite of Kumar et al. as taught by Chen et al. One of ordinary skill would have been motivated to do so because Chen teaches that use of coatings to fertilizers, herbicides or pesticides promote retention of active ingredients or agricultural compounds in the soil, such that they are readily available to the plants and vegetations and protects them from pests.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (Carbohydrate polymers 101 (2014) 1061-1067) in view of Richter et al. (CS196329 (B2); translation of record), Pang et al. (CN 104326836A; translation of record) and further in view of Daemi et al. (Scientia Iranica F (2012) 19 (6), 2023-2028) and Roy et al. (Carbohydrate polymers 76 (2009) 222-231).
The references discussed above do not teach use of calcium alginate nanoparticles.
Daemi et al. teaches calcium alginate nanoparticles as excellent carriers in drug delivery systems and encapsulation agents, see abstract and page 2024, 1-7, left column.
Roy et al. teaches use of calcium alginate microspheres for loading pesticide/insecticide for controlled, slow and safer release of the agent, see title, abstract and Introduction on page 222. On page 223, column 1, second paragraph, the reference discloses that several properties of alginate, like its biodegradability (Lee, Sookim, & Dokim, 2005), immunogenicity (Suckow et al., 2000) and ability to form gel with a variety of crosslinking agents in mild and aqueous conditions, make it a potential carrier for controlled delivery of biologically active agents.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized calcium alginate nanoparticles in place of sodium alginate nanoparticles of Kumar et al. One of ordinary skill would have been motivated to do so because the desired feature of Kumar et al. is controlled delivery of active ingredient, Daemi et al. teaches calcium alginate nanoparticles as excellent carriers in drug delivery systems and encapsulation agents; and Roy teaches that several properties of alginate, like its biodegradability, immunogenicity and ability to form gel with a variety of crosslinking agents in mild and aqueous conditions, make it a potential carrier for controlled delivery of biologically active agents such as pesticides/insecticides/herbicides etc.
Applicant argues that one of ordinary skill in the art would not be motivated to combine the teachings of Kumar, Richter, and Pang to arrive at the present claims because the references relate to different fields as compared to the present claims, leaving the skilled person with no motivation to combine their teachings. Kumar discusses the use of sodium alginate nanoparticles for delivery of imidacloprid pesticide, wherein the use of such pesticides directly affect the pathogen. The disclosure in Kumar doesn't contain any disclosure relating to stimulation of hypoxia-induced nitric oxide and defense pathway induction. Richter discusses different plant growth regulators, including sodium dithionite or potassium dithionite, and Pang discusses the preparation of a straw granule inorganic microbial fertilizer not related to enhancement of defense. By contrast, the present claims are directed towards a nanoparticle formulation for inducing a plant defense response.
Applicant’s arguments are fully considered but is not persuasive. In response to applicant’s assertion that the disclosure in Kumar doesn't contain any disclosure relating to stimulation of hypoxia-induced nitric oxide and defense pathway induction, it is pointed out that in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Same reasoning holds for applicant’s arguments that the present claims are directed towards a nanoparticle formulation for inducing a plant defense response which is not taught by the references. First the claims do not recite such limitations, therefore, it is noted that the features upon which applicant relies are not recited in the rejected claims. Additionally, Kumar explicitly teaches that pesticide loaded sodium alginate nanoparticles, see title. Kumar et al. teaches with the help of nanotechnology, controlled release of agrochemicals, site targeted delivery of various macromolecules desired for improved plant disease resistance, enhanced plant growth and efficient nutrition utilization can be easily done. And Richter et al. which is in the same filed on endeavor discloses plant growth regulators that can be used in agriculture, (in particular to promote crop growth in agriculture), teaches sodium dithionite or potassium dithionite wherein they are characterized as a plant growth regulator salts. Therefore, use of dithionite and nitrite salts as taught by Richter and Pang et al would have been obvious to have used for encapsulation by sodium alginate motivated by the teachings of Kumar et al. disclosing the benefits of encapsulation by teaching that nanoencapsulation has an advantage of safer handling and more efficient use of pesticides with less exposure to environment that guarantees eco-protection. In plant entomology, nanotechnology targets specific agricultural problems in plant pests interaction and provide new ways for crop protection. It is well-established that the examiner is not bound by applicants' rationale for combining elements recognized as suitable by the prior art; any rationale provided by the art to drive the skilled artisan's combination of these elements will suffice to render their combination obvious. MPEP 2144(IV).
Applicant states that the present claims possess unexpectedly superior properties not disclosed, taught, or suggested by any of the cited references. The pending claims are directed to a nanoparticle formulation comprising sodium dithionite and at least one nitrite. The application of sodium dithionite in the form of nanoparticle formulation creates local hypoxia in leaves and that leads to enhanced nitric oxide (NO) production via activation of nitrate reductase which further leads to induction of salicylic acid (SA), thereby inducing the defense responses in plants locally and systemically to entire plants. This has been shown in the Examples 1 and 2 of the specification, wherein the nanoparticle formulation was shown to induce plant's innate response against infection of Xanthomonas axonopodis pv. Punicae and Pseudomonas syringae. Additionally, the Applicant refers to paragraph [0081] of Example 3 wherein the Applicant has demonstrated that "Figure 9A discloses the effect of the nanoparticle formulation comprising Sodium dithionite to induce the defense response in the plants, wherein sodium dithionite nanoparticle formulation treated plants were further infected with virulent Pseudomonas syringae (10⁸ cfu/ml). Symptoms were observed at 4th day post infection from control and sodium dithionite nanoparticle formulation treated plants. Similarly, sodium dithionite nanoparticle formulation treated pomegranate plants were infected with Xanthomonas axonopodis pv. punicae (XAP), as shown in Figure 9B. It can be inferred from Figure 9B that defense response against XAP were induced in nanoparticle formulation as compared to control plants. Further, it has been stated in paragraph [0082] that "The application of sodium dithionite in the form of nanoparticle formulation creates hypoxia and leads to increase in the nitric oxide (NO) production which further leads to induction of salicylic acid (SA), thereby inducing the defense responses in plants."
These arguments are not persuasive. Kumar et al. as discussed above teach that with the help of nanotechnology, controlled release of agrochemicals, site targeted delivery of various macromolecules desired for improved plant disease resistance, enhanced plant growth and efficient nutrition utilization can be easily done. So, the plant defense response is taught by the prior art. However, it is not clear whether the magnitude of the effect of the inventive formulation is any better. No comparative experiments have been presented, and it is unclear whether there is any difference between the inventive formulation and the known plant defense taught by the prior art. And the tests used in a comparison must be made under identical conditions except for the novel features of the invention. See MPEP 716.02(e). As such a comparison has not been presented, the argument are not found persuasive.
Applicant argues that Chen discloses maltodextrin as just one of the substances in a laundry list of similar substances that can be used for coating a seed. There is no teaching or motivation for a skilled person to specifically select maltodextrin, which has been defined as a binder/filler in Chen (refer, paragraphs [0041] and [0044] of Chen) and use it as a coating agent for a nanoparticle formulation. A skilled person would be aware that a nanoparticle formulation is fundamentally different from a seed; further, they could also select, for instance, underivatized guar or cationic hydroxypropyl guar for coating a nanoparticle formulation, going by the reasoning provided in the Office Action.
These arguments are not persuasive. Chen et al. explicitly teaches seed coatings wherein the seeds coatings can be maltodextrin and an active ingredient can be plant growth regulator, see [0016], [0041] and [0044]. While several other coating agents are disclosed, use of maltodextrin was known in the art and therefore, it would have been obvious to one of ordinary skill to have used the same for coating function. Furthermore, it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Applicant argues that Daemi and Roy are cited as allegedly teaching teach the use of calcium alginate nanoparticles in drug delivery systems. However, a skilled person looking to prepare a nanoparticle formulation for inducing plant defense responses would not have any motivation to refer to Daemi, which discuss synthesis and characterization of calcium alginate nanoparticles and their use in drug delivery systems, and Roy, which discusses the dynamics of controlled release of chlorpyrifos, since the field of endeavor is completely different from the present claims. Even if the skilled person referred to Daemi and Roy, a combination of the disclosures of Kumar, Richter and Pang, with Daemi and Roy would lead the skilled person to multiple sodium alginate nanoparticle formulations or calcium alginate nanoparticle formulations comprising a multitude of plant growth regulators (for instance, sodium alginate nanoparticles comprising sodium or potassium chloride), and potassium chloride, with several coating agents used for coating the nanoparticle formulation. Arriving at the specific combination of a calcium alginate nanoparticle comprising sodium dithionate and potassium nitrite with maltodextrin as a coating agent would require undue experimentation on the part of the skilled person and given that Pang does not disclose a nitrite, it would only be possible with hindsight knowledge of the present claims.
These arguments are not persuasive. As discussed in the rejections above, Daemi et al. explicitly teaches calcium alginate nanoparticles as excellent carriers for encapsulation agents and Roy et al. explicitly teaches use of calcium alginate microspheres for loading pesticide/insecticide for controlled, slow and safer release of the agent. Therefore, it would have been obvious to one of ordinary skill to have utilized calcium alginate nanoparticles to encapsulate dithionite and nitrite of Richter et al and Pang et al in place of sodium alginate of Kumar et al. with an expectation of obtaining similar results. 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).
Action is final
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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