FINAL 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 the Claims
This action is in response to papers filed 06/23/2026 in which claims 1-12, 14, 16-18, and 23 were canceled; claims 15 and 19-22 were withdrawn; and claim 13 was amended. All the amendments have been thoroughly reviewed and entered.
Claims 13 and 24 are under examination.
Withdrawn Rejection
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Modified Rejection
Necessitated by Applicant’s Claim Amendments
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 13 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah (US 2013/0253054 A1; hereafter as “Shah ‘054”) in view of Yan et al (US 2017/0105418 A1), Shah (US 2013/0302446 A1; hereafter as “Shah ‘446”), Skillman et al (US 2015/0087622 A1), and Yang et al (US 2013/0196071 A1).
Regarding claim 13, Shah ‘054 teaches a ZC composition comprising a microcapsule formulation containing lambda cyhalothrin, and a suspension concentrate containing diafenthiuron (Abstract; [0007]-[0016]. [0024], [0029], [0034], [0120]; claims 1-2). Shah ‘054 teaches the composition showed higher effectiveness against pest population at lower dosages and for a longer period of time, thus reducing the impact of bioaccumulation on the environment ([0007], [0034] and [0120]).
However, Shah ‘054 does not teach the soybean oil or derivative thereof that solubilized the pyrethroid insecticide in the microencapsulate formulation; the microcapsule have a D50 particle size in a range from 0.1 µm to 10 µm; the novaluron as the active ingredient in the suspension concentrate; and the soybean oil or derivative thereof is present in an amount from 0.1% to 50% by weight, of claim 13.
Regarding the soybean oil that solubilized the pyrethroid insecticide in the microencapsulate formulation, the amount of soybean oil, and the microcapsules D50 particle size of claim 13, Yan teaches an insecticide composition comprising microcapsules containing an outer polymeric shell encapsulating a core containing pyrethroid such as lambda cyhalothrin, wherein the pyrethroid dissolved in a vegetable oil selected from soybean oil, epoxidized soybean oil, coconut oil, olive oil, safflower oil, cotton seed oil, corn oil, rape seed oil, or combination thereof (Abstract; [0008]-[0013], [0023]-[0040], [0063], [0065] and [0078]; claims 1-24). Yan teaches the core can contain only the vegetable oil as the solubilizer or dispersing agent which dissolves the insecticide ([0039]-[0040]; claims 5 and 8-9). Yan teaches the microcapsule formulation of pyrethroid such as lambda cyhalothrin provides a high loading and high efficacy insecticide formulation while also reducing toxicity of the formulation thereby improving the safety profile not only for the consumer but also in the local environment ([0012]-[0013], [0023] and [0078]). Yan teaches the amount of vegetable oil used to dissolve pyrethroid is predetermined and can be vary for example, at a weight ratio of pyrethroid to vegetable between 6:1 to 10:1 such as 39.67% by weight pyrethroid and 6.4% by weight vegetable oil of the formulation ([0075], [0087]-[0088], Table 1). Yan teaches the microcapsules have mean particle size (D50) of 10 micrometer or less ([0011], [0037], [0088]; Table 2; claims 33 and 36).
Regarding the novaluron as the active ingredient in the suspension concentrate, Shah ‘446 teaches a suspension concentrate formulation containing an insecticide selected from diafenthiuron and novaluron (Abstract; [0007]-[0008], [0012], [0014], [0016], [0032]-[0033]; Tables 8 and 9; claims 1, 4 and 6).
It would have been obvious to one of ordinary skill in the art to modify the ZC composition of Shah ‘054 such that the microcapsule containing pyrethroid such as lambda cyhalothrin is dissolved in vegetable oil such as soybean oil per Yan that is then incorporated as the microcapsule formulation, and novaluron is substitute or incorporated as the insecticide in the suspension concentrate formulation of Shah ‘054 per guidance from Shah ‘446, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Shah ‘446 provides the guidance for substituting or incorporating novaluron in place of diafenthiuron as the insecticide of the suspension concentration, as Shah ‘446 indicates that both diafenthiuron and novaluron are suitable insecticide for formulating in a suspension concentrate. One of ordinary skill in the art would have reasonable expectation of success of making said modification to the ZC composition of Shah ‘054 because Skillman indicated that lambda cyhalothrin is known to be useful in combination with benzoylurea insecticide such as novaluron to provide immediate insecticide/pesticide effects or fast acting knock-down effect, as well as long-term effect against pests/insects (Skillman: [0004], [0009], [0012]-[0013], [0036] and [0040]-[0046]; claims 1, and 4-5). Thus, it is noted that [t]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.). As such, an ordinary artisan seeking to formulate an highly efficacious insecticide combination formulation of lambda cyhalothrin and a benzoylurea insecticide such as novaluron, would have looked to modify the ZC composition of Shah ‘054 such that the microcapsule containing pyrethroid such as lambda cyhalothrin is dissolved in vegetable oil such as soybean oil per Yan that is then incorporated as the microcapsule formulation, and novaluron is substitute or incorporated as the insecticide in the suspension concentrate formulation per guidance from Shah ‘446 and Skillman so as to provide a resultant ZC composition having higher effectiveness against pest population at lower dosages and for a longer period of time, thus reducing the impact of bioaccumulation on the environment, as required by Shah ‘054, and achieve Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to routinely optimize the concentration of vegetable oil such as soybean oil used for dissolving pyrethroid in the formulation to an amount from 0.1% to 50% by weight of the co-formulation, and produce the claimed invention. One of ordinary skill the art would have been motivated to do so because Yan teaches that the amount of vegetable oil such as soybean oil used to dissolve pyrethroid is predetermined and can be vary for example, at a weight ratio of pyrethroid to vegetable oil between 6:1 to 10:1 such as 39.67% by weight pyrethroid and 6.4% by weight vegetable oil of the formulation (Yan: [0040], [0075], [0087], Table 1; claim 8), which are amounts with falls within or overlaps the claimed range of an amount from 0.1% to 50% by weight for soybean oil or derivative thereof. While the example is to corn oil as the vegetable oil, soybean oil is taught as functionally equivalent to corn oil as the vegetable oil for use in solubilizing the pyrethroid. Thus, said amount of corn oil as the vegetable oil as taught in the Example from Yan supra would be reasonably pertinent for use in all functionally equivalent vegetable oil including soybean oil. As such, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of vegetable oil such as soybean oil in the co-formulation would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
It would also have been obvious to one of ordinary skill in the art to routinely optimize the microcapsules of Shah ‘054 to have a D50 particle size in a range from 0.1 µm to 10 µm, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Yan provided the guidance to do so by teaching that microcapsules containing a pyrethroid such as lambda cyhalothrin of Shah ‘054 can be routinely optimize to have a D50 particle size of 10 micrometer or less (Yan: [0011], [0037], [0088]; Table 2; claims 33 and 36). Thus, absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the D50 particle size of the microcapsules would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
With respect to the claimed “the free lambda-cyhalothrin content is 0.1-0.6% of the total lambda-cyhalothrin” as recited in claim 13, Yan teaches that the microcapsules encapsulating a pyrethroid such as lambda cyhalothrin have high loading, high efficacy, and reduce oral toxicity due to forming microcapsules having polyurethane shell wall via interfacial polymerization (Yan: [0009], [0013], [0019], [0023], [0031]-[0035], [0036]-[0038], [0072], [0078], [0080], [0082]; claim 3, 33 and 38). Yan teaches polyurethane is formed via reacting isocyanate with a di- or tri-glycol ([0035]). Thus, it would have been obvious to one of ordinary skill in the art to prepare the microcapsules of Shah ‘054 using known technique or process of interfacial polymerization, particularly, preparing the microcapsules of Shah ‘054 to have polyurethane shell wall via interfacial polymerization so as to provide resultant microcapsules with high loading, high efficacy, and reduce oral toxicity, and thereby implicitly achieve a free lambda-cyhalothrin content of 0.1-0.6% of the total lambda-cyhalothrin. This is because Shah ‘054 objective is to provide a stable suspension of capsules and per evident from Yang, polyurethane microcapsule is formed from interfacial polymerization of an isocyanate with a diol such as propylene glycol in an aqueous solution, and said polyurethane microcapsule exhibit improved stability, high loading, and low leakage (Yang: Abstract; [0006]-[0040], [0051]-[0075]; claims 1-20). Thus, an ordinary artisan would have looked to prepare the microcapsules of Shah ‘054 using known technique or process of interfacial polymerization, particularly, preparing the microcapsules of Shah ‘054 to have polyurethane shell wall via interfacial polymerization of an isocyanate with a diol such as propylene glycol so as to provide resultant microcapsules having high loading and reduced toxicity due to improved microcapsule stability and low leakage of pyrethroid (lambda-cyhalothrin), and achieve Applicant’s claimed invention with reasonable expectation of success.
With respect to the claimed property of “the co-formulation maintains a spontaneity of dispersion above 90% after storage at 54±2°C for 14 days under accelerated storage conditions” as recited in claim 13, as discussed above, it is noted that Shah ‘054 teaches a ZC composition. Shah ‘054 teaches the a ZC formulation is known to be a stable suspension of capsules and active ingredient, in fluid, normally intended for dilution with water before use (Shah ‘054: [0014] and [0016]). Thus, claimed property of “the co-formulation maintains a spontaneity of dispersion above 90% after storage at 54±2°C for 14 days under accelerated storage conditions” would have been reasonably obvious as being an implicit property in the ZC composition of Shah ‘054 in view of Yan, Shah ‘446, Skillman, and Yang, absence of evidence to the contrary.
Regarding claim 24, Shah ‘054 teaches the composition contains lambda cyhalothrin in an amount in the range of 0.5% to 12% by weight (Shah ‘054: [0008], [0012], [0024]; claims 1 and 5). Shah ‘446 teaches the formulation containing novaluron in an amount in the range from 0.1% to 40% of the weight (Shah ‘446: [0014]-[0015]; claims 1-2). Skillman teaches lambda cyhalothrin and novaluron are used in combination in a pesticidal composition at weight ratio of 1:10 to 10:1 (Skillman: [0042]). The weight amounts of lambda cyhalothrin and novaluron as taught by Shah ‘054, Shah ‘446, and Skillman falls within or overlaps the claimed ranges of “the lambda-cyhalothrin is present in an amount from about 0.1% to about 60% w/w of the co-formulation, and novaluron is present in an amount from about 0.1% to about 60% w/w of the co-formulation” as recited in claim 24. It would have been reasonably obvious to routinely optimize the amounts of lambda cyhalothrin and novaluron in a co-formulation in view of the guidance from Shah ‘054, Shah ‘446, and Skillman. Thus, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amounts of lambda cyhalothrin and novaluron in the co-formulation would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06/23/2026 have been fully considered but they are not persuasive.
Applicant argues “A general statement that a ZC formulation is a "stable suspension" does not establish that the proposed modified formulation described in the Office action would necessarily or predictably maintain spontaneity of dispersion above 90% after storage at 54 ±2 °C for 14 days.” Applicant alleges “[t]he claimed property is a specific, quantitative performance requirement measured under defined accelerated storage conditions, not a generic consequence of preparing any ZC formulation.” Applicant alleges “the specification confirms that this performance for the claimed formulations. The application reports a defined accelerated storage test at 54 ±2 °C for 14 days and shows spontaneity of dispersion above 90% after that test. See application as filed, paras. [0250]- [0251] and Table 1.” (Remarks, pages 5-6).
In response, the Examiner disagrees. As described in Table 1 of the specification, the formulation is a “ZC formulation” (Specification: pages 43-44), and as discussed in the 103 rejection, Shah ‘054 established that a ZC formulation is known to be a stable suspension of capsules and active ingredient, in fluid, normally intended for dilution with water before use (Shah ‘054: [0014] and [0016]). Thus, it is maintained that claimed property of “the co-formulation maintains a spontaneity of dispersion above 90% after storage at 54±2°C for 14 days under accelerated storage conditions” would have been reasonably obvious as being an implicit property in the ZC composition of Shah ‘054 in view of Yan, Shah ‘446, Skillman, and Yang, absence of evidence to the contrary. To this end, Applicant have not shown otherwise by showing via objective evidence that not all ZC formulation/composition would provide a spontaneity of dispersion above 90% after storage at 54±2°C for 14 days under accelerated storage conditions as claimed. In the absence of objective evidence to the contrary, the claimed property of “the co-formulation maintains a spontaneity of dispersion above 90% after storage at 54±2°C for 14 days under accelerated storage conditions” would have been reasonably obvious as being an implicit property in the ZC composition of Shah ‘054 in view of Yan, Shah ‘446, Skillman, and Yang, because as discussed above, Shah ‘054 established that a ZC formulation is known to be a stable suspension of capsules and active ingredient, in fluid.
Furthermore, Applicant’s alleged data shown in Table 1 is also not persuasive to obviate the 103 rejection of the combined teachings of Shah ‘054,Yan, Shah ‘446, Skillman, and Yang because claim 13 is not adequately commensurate in scope with the ZC formulations of Examples 8 and 9 from Table 1 that were used for showing the stability data. Per MPEP §716.02(d), [w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support."
Applicant argues “[t]he present Amendment further distinguishes the claims because the cited art does not teach forming the polymeric shell wall by interfacial polymerization in the presence of an aqueous phase comprising propylene glycol in the claimed lambda-cyhalothrin and novaluron co-formulation.” Applicant alleges “[t]he specification describes propylene glycol as part of the capsule-forming aqueous phase and explains that aliphatic diols can participate in shell wall formation by reacting with isocyanate to form polyurethane polymers that crosslink with polyurea polymers.” Thus, Applicant alleges “[t]he Office action has not identified any teaching or rationale in the cited references that would have led a person of ordinary skill to make this specific formulation modification with a reasonable expectation of achieving the claimed accelerated storage dispersion performance.” (Remarks, page 6, 2nd paragraph).
In response, the Examiner disagrees. It is first noted that claim 13 recites broadly “the polymeric shell wall is formed by interfacial polymerization in the presence of an aqueous phase comprising propylene glycol.” Claim 13 is not drawn to “shell wall formation by reacting with isocyanate to form polyurethane polymers that crosslink with polyurea polymers,” but rather the claimed “the polymeric shell wall is formed by interfacial polymerization in the presence of an aqueous phase comprising propylene glycol” is broad to encompass polyurethane microcapsules. It is noted that the features upon which applicant relies (i.e., shell wall formation by reacting with isocyanate to form polyurethane polymers that crosslink with polyurea polymers) are not recited in the rejected claim(s) 13. 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).
As such, given that “the polymeric shell wall is formed by interfacial polymerization in the presence of an aqueous phase comprising propylene glycol,” as recited in claim 13 is broad to encompass polyurethane microcapsules, it is maintained, as discussed in the standing 103 rejection, that it would have been obvious to one of ordinary skill in the art to prepare the microcapsules of Shah ‘054 using known technique or process of interfacial polymerization, particularly, preparing the microcapsules of Shah ‘054 to have polyurethane shell wall via interfacial polymerization so as to provide resultant microcapsules with high loading, high efficacy, and reduce oral toxicity, and thereby implicitly achieve a free lambda-cyhalothrin content of 0.1-0.6% of the total lambda-cyhalothrin. This is because Shah ‘054 objective is to provide a stable suspension of capsules and per evident from Yang, polyurethane microcapsule is formed from interfacial polymerization of an isocyanate with a diol such as propylene glycol in an aqueous solution, and said polyurethane microcapsule exhibit improved stability, high loading, and low leakage (Yang: Abstract; [0006]-[0040], [0051]-[0075]; claims 1-20). Thus, an ordinary artisan would have looked to prepare the microcapsules of Shah ‘054 using known technique or process of interfacial polymerization, particularly, preparing the microcapsules of Shah ‘054 to have polyurethane shell wall via interfacial polymerization of an isocyanate with a diol such as propylene glycol so as to provide resultant microcapsules having high loading and reduced toxicity due to improved microcapsule stability and low leakage of pyrethroid (lambda-cyhalothrin), and achieve Applicant’s claimed invention with reasonable expectation of success.
As a result, for at least the reasons discussed above, claims 13 and 24 remained rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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