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 .
Applicant’s arguments, filed 10/17/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Status
Claims 1-5 and 7-14 are pending and under examination.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gewehr (EP 3269246 A1) in view of Cristau et al (US 20160262393 A1, newly cited reference).
Gewehr teaches pesticidal mixtures comprising tetrazolinone and carboxamide, where the tetrazolinone is 1-[2-[[1-(4-chlorophenyl)pyrazol-3-yl]oxymethyl]-3-methyl-phenyl]-4-methyl-tetrazol-5-one (compound I-3) (abs, ¶¶ 33, 36). The carboxamide compound is a fungicidal compound (¶ 18). The weight ratio of the tetrazolinone compound to the carboxamide compound is from 500:1 to 1:500 (¶ 24). The mixture can further include a liquid or a solid carrier (claim 9). Gewehr also teaches a method to protect plant propagation material (preferably seed) from harmful pests, including fungi or animal pests, by contacting the plant propagation materials with the pesticidal mixtures in effective amounts, thereby promoting a synergistic effect that improves plant health (abs, ¶¶ 4, 8, 33, and 36). Fungal plant diseases than can be treated include Microdochium nivale on cereals (e.g., wheat or barley), P. teres on barley, P. striiformis on wheat, barley, or rye, etc. (¶ 63). The mixture is applied simultaneously or in succession, in an amount from 0.01 g to 10 kg per 100 kg of plant propagation material, where the combination of actives enhanced control of harmful fungi and health effects compared to treatments with the individual compounds (¶¶ 21-22, claims 13-15).
Gewehr is discussed above but does not teach N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5- fluoro-1-methyl-1H-pyrazole-4-carboxamide as the carboxamide.
Cristau et al teaches active compound combinations for controlling the phytopathogenic fungi of plants or crops, such as by treating seeds, with a fungicide composition (abs). The combination comprising (A) N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-l-methyl-lH- pyrazole-4-carboxamide (compound A5), and (B) a further fungicidally active compound (abs). The combinations achieves synergistic effect, where compound (A) with compound (B) allows for lowered rates of application while the fungicidal action remains equally good, the combination achieves a high degree of phytopathogen control, increased activity of the compounds, etc. (¶¶ 6-7, 279, 284). The synergistic effect is particularly pronounced at certain weight ratios, in a range of 1000:1 to 1:1000, more preferably 50:1 to 1:50, even more 20:1 to 1:20 (¶¶ 252-253). Examples A-F show the efficacy of the compounds used alone and in combination, where the compounds used in combination had a higher found efficacy than those that were calculated using Colby’s formula, where every embodiment showed synergy across different fungicides, phytogenic pathogens, different plants, and weight ratios, ranging from 3-85% synergy (calculated from the difference between the found and calculated efficacy) (Examples A-F). The compounds were used for the treatment and protection of seeds, plants, or plant parts comprising applying the composition to the seeds, plants, etc. (abs, ¶¶ 259, 272). The compositions are suitable for protecting cereals, such as wheat, barley, rye, etc. (¶ 280). The compositions can treat Pyrenophora teres on barley, septoria tritciti on wheat, etc. (¶ 373, ex. C, D).
Regarding active compounds of claim 1, it would have been obvious modify Gewehr by substituting the carboxamide compound with other fungicidal carboxamides that are used in combination with other fungicidal actives that are known to be suitable for controlling phytopathogenic pests, such as N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-l-methyl-lH- pyrazole-4-carboxamide, as taught by Cristau et al, as a matter of substituting equivalents known for the same purpose. See MPEP 2144.06. Further, where Gewehr teaches synergy between compound I and a carboxamide fungicidal active, and where Cristau et al teaches instant compound II (comprising a carboxamide group) has synergy with other fungicides, it would be expected that by combining compound I and compound II, synergy in the efficacy would occur, compared to those used individually.
Regarding the weight ratio of compounds I and II of claim 1 and 14, it would have been obvious to select a ratio of instant compounds I and II from 20:1 to 1:20, where Cristau et al teaches these ratios particularly result in synergy, and where Gewehr teaches a ratio of 500:1 to 1:500 is suitable. See MPEP 2144.05.
Regarding the active steps of the method of claim 1, it would have been obvious to use the combination of Gewehr and Cristau et al for the method of treating a plant propagation material, etc., with an effective amount of the fungicidal mixture made obvious above, as taught by Gewehr.
Regarding claims 2-5, it would have been obvious to use the pesticidal mixture made obvious by Gewehr and Cristau et al above, for controlling Microduchium nivale on wheat, Pyrenophera teres on barley, Puccinia striiformis on wheat, barley, or rye, etc., where Gewehr teaches controlling as discussed above.
Regarding claim 7, it would have been obvious to contact the plant propagation material with the pesticidal mixture made obvious by Gewehr and Cristau above, where Gewehr teaches contacting plant propagation materials, etc., with the mixtures in effective amounts, as discussed above, where both are directed to mixtures for controlling pests on plant materials.
Regarding the weight ratio of claim 7, it would have been obvious to include compounds I and II in a ratio from 20:1 to 1:20, for the same reasons discussed above by Gewehr and Cristau et al.
Regarding claim 8, it would have been obvious to apply the mixture in an amount from 0.01 g to 10 kg per 100 kg of plant propagation material, as taught by Gewehr.
Regarding claim 9, it would have been obvious to apply the mixture simultaneously, either jointly or separately, or in succession, as taught by Gewehr.
Regarding claims 10 and 11, Gewehr and Cristau et al are discussed above for teaching a composition comprising compounds I and II in a weight ratio from 20:1 to 1:20, as discussed above. Note, the preambles are directed to intended uses which are met where the actives and ratios are present. MPEP 2112.01(II).
Regarding claim 12, it would have been obvious to select a ratio of instant compounds I and II from 20:1 to 1:20, as taught by Cristau et al above and for the same reasons. See MPEP 2144.05.
Regarding claim 13, it would have been obvious to include a liquid or solid carrier to the pesticidal mixture, as taught by Gewehr.
Response to Arguments
First, as previously argued, Applicants assert the carboxamide of Gewehr has a specific generic formula that differs from instant compound II, where the only similarity is the carbamide functional group. Applicants assert that compound B of Gewehr is selected from an extensive list of 93 total compounds, none of which are claimed compound I.
Second, Applicants assert Cristau et al contains examples showing synergism between compositions containing claimed compound II and various fungicides B, and notes that synergism is not demonstrated in all examples (see table 1, ¶ 450). Further, Applicants assert Cristau et al merely shows synergism between metyltetraprole (claimed compound I) and one particular fungicide. Applicants also assert the synergism of Gewehr cannot be extrapolated to synergy between metyltetraprole and all fungicides. Accordingly, Applicants assert in view of the differences in structure between the claimed carboxamide and the carboxamides of Cristau et al, a skilled artisan could not have expected or predicted that combining tetrazoline of Cristau et al with a carboxamide of Gewehr would lead to a combination showing a synergistic fungicidal effect.
Third, Applicants assert that the interaction of active ingredients in a target organism can result in unpredictable effects and asserts that synergy is not a fungible property that is demonstrated when another herbicide is substituted for a particular herbicide in the synergistic mixture. Applicants assert the claimed invention is not merely a straightforward or expected combination of prior art elements, but rather a thoughtful and deliberate innovation that overcame the pitfalls commonly associated with a random combination of known components.
Fourth, Applicants assert the claimed fungicidal mixture demonstrates an unexpected synergistic effect that could not have been predicted. Applicants assert synergism is demonstrated in the tables at pages 10 and 11, where synergism is said to be shown for weight ratios of compound I to compound II at 1:4, 1:1, 4:1, and 16:1. Applicants assert synergism ranging from 38-92%. Applicants again assert this synergism could not have been predicted. Applicants assert they have met their burden of presenting evidence commensurate in scope with the instant claims, where a very specific binary mixture, wherein the individual components are present over a limited weight range.
First, respectfully, this argument is not persuasive. While the examiner agrees that the carboxamide of Gewehr has a different structure than instant compound II, Gewehr teaches that the carboxamides are herbicidal actives, and that when compound I and the carboxamide herbicidal actives are combined, synergy is obtained. Therefore, it would have been obvious to look towards Cristau et al for alternative herbicidal actives that were known to have a synergistic effect when combined with other herbicidal actives, as discussed above.
Second, respectfully, this argument is not persuasive. Applicants assert that synergism is not demonstrated in all examples in table 1 at paragraph [0450] of Cristau et al, however, looking at the table, which appears to be Table D1, all of the tested combinations had synergy where the found activity was greater than the calculated activity, which is taught in paragraph [0450] to be synergistic. The examiner notes that it was not just one compound that showed synergy with instantly claimed compound II, but multiple throughout the tested examples. With that being said, the examiner agrees that it does not appear that the synergy shown in the examples of Gewerh can be extrapolated to synergy between metyltetraprole (compound I) and all fungicides, where the interactions between compound I and any fungicidal active could not reasonably be predicted without testing. While Applicants have shown synergism for the claimed combination of compound I and compound II, in specific ratios, synergism has not been shown across the whole scope of the claim, and a skilled artisan would not reasonably extend the results to all phytopathogenic pests, where the instant results only test the claimed combination against Microducium nivale and Septoria tritici, which is discussed in further detail below.
Third, respectfully, this argument is not persuasive. The examiner does agree that the interaction of active ingredients in a target organism can result in unpredictable effects, and that any combination of two fungicidal actives would not be expected to have synergistic activity against a particular target organism, in specific ratios and concentrations. While it does appear that Applicants have shown some synergy of the claimed combination against two phytopathogenic pests at particular ratios, this synergy does not appear to be demonstrated across the entire scope of the instant claims. Applicants’ argument regarding the interaction of active ingredients in a target organism appears to support the examiner’s position that the results are not commensurate in scope with the claims, where it is said that unpredictable effects can occur, suggesting that the interaction of the active ingredients with other target organisms can be difficult to predict.
Fourth, respectfully, this argument is not persuasive. Applicants assert an unexpected synergistic effect is shown in the tables on pages 10 and 11 of the instant specification, however, the tables only show synergism against Microducium nivale at 1:4 and Septoria tritici on wheat at ratios of 1:4, 1:1, 4:1, and 16:1, and at very specific concentrations. While it does appear that synergy is shown in the tested embodiments, synergy is not shown across the entirety of the scope of the instant claims. It does not appear that the results can be reasonably extended to all phytopathogenic pests, and across the entire weight ratio range, and across all concentrations, where the interaction of active ingredients in a target organism can result in unpredictable effects, as indicated by Applicants on pg. 8 of their response. To provide further support, the tables show that at a concentration of 1:4, synergism was 38% on Microducium nivale, but was 45% for Septoria tritici, which shows that the same composition in the same ratios on different phytopathogenic pests, result in different levels of activity. Additionally, independent claim 7 does not require pest treatment where the claim is directed to protecting plant propagation material, and allows for protection against any pest, which can include insects, animals, weeds, etc. Independent claims 10 and 11 are simply directed to a composition comprising the two compounds, with no phytopathogenic pest treatment requirements. Accordingly, it does not appear that the results presented by Applicants are commensurate in scope with the instant claims. See MPEP § 716.02(d).
While Applicants have amended the claims to narrow the range of weight ratios for compounds I and II, data provided does not appear to show a definitive trend in the percent synergism approaching the upper and lower limits of the range, which is especially true in the case of the Microducium nivale embodiment, where only a 1:4 ratio was tested. While Applicants do not have to test every weight ratio, Applicants have to provide proof of a trend in the exemplified date which would allow the skilled artisan to reasonably extend the probative value. See MPEP § 716.02(d).
Regarding the teachings of the prior art, Gewerh teaches compound I in combination with a carboxamide, which has synergistic effects, however, as asserted by Applicants, the carboxamide has significant differences in structure compared to the carboxamide of claimed compound II (see pg. 6 of Applicants response). Likewise, Cristau et al teaches compound II in combination with other fungicidal active ingredients were known to have synergy, however, instantly claimed compound I does not appear to be one of the listed fungicidal active ingredients. In view of these differences, and upon further review, the examiner does agree that it does not appear that the skilled artisan would have reasonably expected that the combination of compound I and compound II, in the specific ratios from the instant working embodiments, would have synergistic action against Microduchium nivale and Septoria tritici on wheat, without undue experimentation to test all possible combinations of fungicidal active agents and ratios, and on specific phytopathogenic pests. However, currently, as noted above, the claims do not appear to be commensurate in scope with Applicants’ results.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612