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 07/07/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1-20 are pending.
Claims 11-13 are withdrawn.
Claim Rejections - 35 USC § 112(a) - New Matter
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 14 and 16-20, stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 recites a trinexapac-ethyl concentration of “about 200 to 300 gram/liter.” While appearing to have support for 200 to 300 grams/liter, there does not appear to be support for “about” 200 to 300 grams/liter. Accordingly, the limitation appears to be new matter.
Claim 14 also recites wherein the “weight of the poly(propylene oxide) block… is in the range of about 1750 to 2750 gram/mol.” While appearing to have support for 1750 to 2750 grams/mol, there does not appear to be support for “about” 1750 to 2750 grams/mol. Accordingly, the limitation appears to be new matter.
Claim 20 is also rejected for depending on rejected claim 14.
Claim 16 recites “wherein the weight percentage of the poly(propylene oxide) block… is about 40%”. While appearing to have support for 40%, there does not appear to be support for “about” 40%. Accordingly, the limitation appears to be new matter.
Claim 17 recites “wherein the average molecular weight of the poly(propylene oxide) block… is about 2750 gram/mol.” While appearing to have support for 2750 grams/mol, there does not appear to be support for the “about.” Accordingly, the limitation appears to be new matter.
Claim 18 recites “wherein the weight percentage of the poly(ethylene oxide) block… is about 40%.” While appearing to have support for 40%, there does not appear to be support for “about.” Accordingly, the limitations appear to be new matter.
Claim 19 recites, “wherein the average molecular weight of the poly(propylene oxide) block… is about 2750 gram/mol” and “wherein the weight percentage of the poly(ethylene oxide) block… is about 40%.” While appearing to have support for 2750 grams/mol and 40%, there does not appear to be support for “about.” Accordingly, the limitations appear to be new matter.
Response to Arguments
Regarding claim 14, Applicants assert “about 200 to 300 gram/liter” is supported by the instant specification where the instant specification recites between 200 and 400 gram/liter and between 225 and 300 gram/liter. Further Applicants assert “about 1750 to 2750 gram/mol” is supported by the instant specification where a range of 1700 to 2800 gram/mol is recited.
Respectfully, this argument is not persuasive. The term “about” is not defined by the instant specification, and “about” can be interpreted as anything reasonable, for example +/- 10% or +/- 15%, as typically used in the art, though the Examiner notes “about” is not limited to these examples. “About” includes amounts above and below the upper and lower endpoints, which is not supported by the instant specification. For example, about 200 can be reasonably interpreted to read 170-345 gram/liter (+/- 15%), which clearly includes amounts outside of the supported range. Likewise, “about” includes amounts above and below 1750 and 2750, which can be reasonably interpreted to read, for example, as a range from 1487-3162 gram/mol (+/- 15%), which is outside the supported range.
Regarding claim 15, Applicants assert “about 250” is supported by the instant specification where the instant specification recites between 200 and 400 gram/liter and between 225 and 300 gram/liter.
This argument is persuasive. While the term “about” is not defined, using the typical definition of “about” as used in the art, for example +/- 10% or +/- 15%, the skilled artisan would reasonably recognize “about 250” to fall within the range of 200 and 400 gram/liter. Accordingly, the new matter rejection over claim 15 is withdrawn.
Regarding claims 16, 18, and 19, Applicants assert “about 40%” is supported by the instant specification where a range of 30 and 45% is recited.
Respectfully, this argument is not persuasive. The term “about” is not defined by the instant specification, and “about” can be interpreted as anything reasonable, for example +/- 10% or +/- 15%, as typically used in the art, though the Examiner notes “about” is not limited to these examples. “About” includes amounts above and below the recited percentage, which is not supported by the instant specification. For example, about 40% can be reasonably interpreted to read 46% (+ 15%), which is outside the supported range.
Regarding claims 17 and 19, Applicants assert “about 2750 gram/mol” is supported by the instant specification where a range of 1450-3000 gram/mol is recited.
Respectfully, this argument is not persuasive. The term “about” is not defined by the instant specification, and “about” can be interpreted as anything reasonable, for example +/- 10% or +/- 15%, as typically used in the art, though the Examiner notes “about” is not limited to these examples. “About” includes amounts above and below the upper and lower endpoints, which is not supported by the instant specification. For example, about 2750 can be reasonably interpreted to read as 3162.5 (+ 15%), which is outside of the supported range.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 2, 4-9, 14-16, and 20, stand rejected under 35 U.S.C. 103 as being unpatentable over Schlotterbeck et al (US 20110195839 A1, hereinafter “Schlotterbeck”).
Schlotterbeck teaches stable microemulsion compositions comprising at least one plant protectant with a water solubility of less than 5 g/l at 20 deg C, at least one nonionic surfactant, etc. (abs, ¶ 17). The plant protectants include growth regulators, such as trinexapac ethyl, etc. (¶¶ 148, 248). The nonionic surfactants include propylene oxide/ethylene oxide block cooligomers, including PLURONIC PE, in particular PLURONIC PE 6200 and 6400 (¶ 108). As evidenced by the instant specification, PLURONIC PE 6200 (20% PEO, 1750 g/mol PPO) and 6400 (40% PEO, 1750 g/mol PPO) are a suitable poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) block copolymers (see the table on pp. 4-7 of the instant specification). The nonionic surfactants are from 0.5 to 30 wt% of the compositions (¶¶ 145, 260, claim 36). Embodiments comprise 7.2 g PLURONIC PE 6400, out of a total formulation weight of 100 g (table 2, no. 12). Additional nonionic surfactants include castor oil ethoxylates (¶ 92). The microemulsion compositions further comprise solvents with a water solubility of over 100 g/l at 20 deg C, at least one organic solvent with a water solubility from 2-100 g/l at 20 deg C, etc. (abs). The concentration of active agent is from 0.1-40 wt% (¶ 260). The concentration of the solvents are 1-60 wt% of solvent b), 1-60 wt% of solvent c), and 1-60 wt% of solvent d) (¶ 260).
Regarding claim 1, it would have been obvious to formulate a trinexapac-ethyl composition in the form of a microemulsion, as taught by the reference.
It would have been obvious to include PLURONIC PE6200 (20% PEO, 1750 g/mol PPO) or PLURONIC PE 6400 (40% PEO, 1750 g/mol PPO) in the microemulsion made obvious above, which were known nonionic surfactants suitable for microemulsions comprising trinexapac-ethyl, as taught by the reference.
Regarding claim 2, it would have been obvious to select from PLURONIC PE 6400 (40% PEO, 1750 g/mol PPO), for the same reasons discussed above, thereby meeting the claimed limitations.
Regarding claim 4, where the microemulsions are aqueous based, and the working embodiment of no. 12 comprises 7.2 g/100 g total formulation weight, and based on the density of the aqueous microemulsion formulation which would be expected to be about 1000 g/l, it appears that the amount of PLURONIC PE 6400 is about 72 g/l, falling within the claimed range. Accordingly, when formulating the microemulsion made obvious above comprising trinexapac ethyl, it would have been obvious for the skilled artisan to start with those amounts form the working examples, and adjust from there in order to achieve optimal stability, properties, etc. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claim 5, where about 72 g/l of the block copolymer is calculated and made obvious above, and Schlotterbeck teaches the amount of nonionic surfactant can vary from 0.5 to 30 wt% (i.e., 0.5-30 g/100 g composition, or 50-300 g/l), it would have been obvious for the skilled artisan to adjust the amount of the block copolymer within that range, thereby overlapping the concentration range of claim 5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been obvious for the skilled artisan to routinely adjust the amount of the block copolymer in order to achieve optimal stability of the trinexapac ethyl microemulsion compositions made obvious above. See MPEP 2144.05(II)(A).
Regarding claims 6 and 7, when formulating the microemulsion composition comprising trinexapac ethyl and a block copolymer as instantly claimed, where Schlotterbeck teaches the amount active agent can vary from 0.1 to 40 wt% (0.1 to 40 wt% of active in 100 g of total composition weight, results in about 10-400 g/l of active), it would have been obvious for the skilled artisan to include trinexapac ethyl within the ranges suitable for active agents, as taught by the reference. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of trinexapac ethyl in order to determine the optimal concentrations to achieve desired microemulsion composition activity for desired uses. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claim 8, it would have been obvious to further include castor oil ethoxylates (i.e., a castor oil alkoxylate), a suitable nonionic surfactant taught by Schlotterbeck, and where the reference teaches multiple nonionic surfactants may be included.
Regarding claim 9, where water miscible solvents are made obvious above, and the amount of each solvent ranges from 1-60 wt% of the total microemulsion weight, it would have been obvious for the skilled artisan to adjust within that range. For example, if 100 g of total formulation weight, such as in working embodiment no. 12, the concentration of each solvent can range from 1-60 g, or 10-600 g/l, calculated based on the density of the aqueous microemulsion formulation which would be expected to be about 1000 g/l.
Further, it would have been obvious for the skilled artisan to routinely adjust the amount of the water miscible solvent in order to achieve optimal properties for the trinexapac ethyl microemulsion compositions made obvious above. See MPEP 2144.05(II)(A).
Regarding claim 14, it would have been obvious to formulate a microemulsion composition comprising trinexapac ethyl in concentrations overlapping those instantly claimed, for the same reasons discussed above by Schlotterbeck. Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of trinexapac ethyl in order to determine the optimal concentrations to achieve desired microemulsion composition activity for desired uses. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
It would have been obvious to select from PLURONIC PE 6400 (40% PEO, 1750 g/mol PPO) as the nonionic surfactant, for the same reasons discussed above by Schlotterbeck.
Regarding claim 15, it would have been obvious to formulate a microemulsion composition comprising trinexapac ethyl in concentrations overlapping those instantly a claimed, for the same reasons discussed above by Schlotterbeck. Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of trinexapac ethyl, for the same reasons discussed above. See MPEP 2144.05(II)(A).
Regarding claim 16, where the selection of PLURONIC PE 6400 (40% PEO, 1750 g/mol PPO) is made obvious above, the limitations are met.
Regarding claim 20, it would have been obvious to further include a castor oil ethoxylate (i.e., a castor oil alkoxylate), for the same reasons discussed above by Schlotterbeck.
Response to Arguments
First, Applicants assert Schlotterbeck discloses a broad list of non-ionic surfactants without any teachings that PLURONIC PE 6200 and PE 6400 are preferred or suitable, and none of the experimental examples test formulations of trinexapac-ethyl. Applicants argue the obviousness rejection is based on hindsight.
Second, Applicants assert the claimed copolymers were surprisingly suitable to provide microemulsion compositions which are “technically suitable for real-life applications”, compared to other emulsifiers. Applicants assert the specification at pg. 7, discussing results shown on pp. 4-7, show that one cannot simply substitute any non-ionic surfactant from the prior art into trinexapac-ethyl microemulsion, and the claimed PEO-PPO-PEO block copolymers provide unexpectedly superior performance in terms of microemulsion stability and suitability compared to other classes of non-ionic surfactants. In response to the Examiner’s recitation regarding the shaded portions having varying appearances, Applicants assert the relevant comparison for unexpected results is between the claimed class surfactants (PEO-PPO-PEO block copolymers) and the other surfactant classes, not between individual formulations within the claimed scope. Applicants assert the data clearly establishes that the claimed copolymer as a class provided microemulsions compositions that are technically viable, whereas many other surfactant types (GENAPOL, TETRONIC, and others) simply did not form an acceptable microemulsions with trinexapac-ethyl at all.
Third, Applicants assert antifoam is a minor processing additive that suppresses foam formation, and asserts it has no bearing on the fundamental thermodynamic stability of the microemulsion or the miscibility of the emulsifier with the composition. Applicants asset the Examiner has not provided evidence to support that the presence or absence of antifoam would alter whether a microemulsion can or cannot be formed.
Fourth, in response to the Examiners purely arguendo response that even if unexpected results were established, the data could not be reasonably extended to include any combination in any amounts, Applicants assert the claims are not directed to any combination in any amounts, and are instead a specific formulation type comprising specific ingredients with defined molecular weight and composition ranges. Applicants assert the experimental data supports the criticality of the claimed class of block copolymers for forming suitable trinexapac-ethyl microemulsions.
First, respectfully, this argument is not persuasive. 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). Applicants have not provided any evidence that the rejection is not based on knowledge available to those of ordinary skill in the art. While Schlotterbeck may list other possible non-ionic surfactants, the prior art may be relied upon for all it reasonably teaches, even non-preferred and non-exemplified embodiments. Where Schlotterbeck teaches a microemulsion composition comprising at least one plant protectant and at least one non-ionic surfactant, where suitable plant protectants include trinexapac-ethyl and suitable non-ionic surfactants include PLURONIC PE 6200 and PE 6400, it would have been obvious to select from among those components that are taught to be suitable for microemulsion formulations.
Second, respectfully, this argument is not persuasive. While the examiner recognizes that some of the emulsifiers were not miscible, it is not clear to the examiner what properties the microemulsion compositions must possess to be “technically suitable for real-life applications.” While the tested embodiments had varying appearances and appearances of 1% dilution after 24 hours at 30 °C, it appears that every tested embodiment from the table bridging pp. 4-7 produced microemulsions, as implied by the data listed under ”Appearance of ME” heading; in other words, if the microemulsion had an appearance, it appears a microemulsion was formed. It is not clear to the Examiner what the alleged unexpected improvement is. Applicants assert the proper comparison is to compare the PEO-PPO-PEO block copolymer as a class compared to other emulsifiers, however, the results for the inventive examples must be examined to determine if the comparative emulsifiers are unexpectedly different from the comparative examples. As previously recited, the shaded formulations, which are recited to be within the scope of the claims, had varying microemulsion appearances: formulation 2 had a yellow, transparent-slightly turbid appearance and opaque after 1% dilution after 24 hours at 30 °C; formulation 10 had a slightly turbid appearance and was “opaque emulsion” after 1% dilution after 24 hours at 30 °C; and formulation 18 having a clear yellow/amber solution appearance and “opaque emulsion” after 24 hours after 1% dilution for 24 hours at 30 °C. Formulation 3, while not being shaded, appears to fall within the scope of the instant claims, and was opaque with trace beige sediment after 24 hours under the same dilution as the above formulations. Other embodiments that appear to be outside of the scope of the instant claims also had an opaque appearance (formulations 4 and 13). Formulation 13 was also said to be unacceptable even though it was an opaque emulsion after 24 hours under the same dilution as the above examples, similar to that of the shaded formulations. Further, page 8 of the instant specification recites that of emulsifiers a) (20% PEO, 1750 gram/mol PPO), b) (40% PEO, 1750 gram/mol PPO), c) (40% PEO, 2250 gram/mol PPO), and d) (40% PEO, 2750 gram/mol PPO), only c) and d) exhibited an acceptable chemical stability profile and acceptable shelf life, though all fall within the claimed ranges for the block copolymer, suggesting that even some of the claimed embodiments were determined to be unacceptable. Likewise, the data does not appear to demonstrate a consistent, objective measure for what constitutes an acceptable microemulsion or a microemulsion that is “technically suitable for real-life applications”, as the inventive embodiments, as well as the comparative embodiments, show varying and overlapping data. It is not clear what the alleged advantage the claimed copolymers have compared to other emulsifiers. Based upon the teachings of the prior art discussed above, it appears to be expected that copolymers falling within the ranges instantly claimed would be suitable for formulating a microemulsion comprising trinexapac ethyl, as taught by Schlotterbeck above and for the same reasons. The burden is on applicant to establish that the results are unexpected and significant and explain the data as evidence of non-obviousness. See MPEP 716.02(b) I. and II.
Third, respectfully, this argument is not persuasive. The issue raised regarding antifoam on pg. 17 of the prior Office Action was not whether or not a microemulsions would form, but rather that it is unclear what effect the lack of antifoam from a) and b) from pg. 8 had on trinexapac-ethyl loss, where a) and b) were tested without antifoam and c) and d) were tested with antifoam. The only embodiment that appears to have been tested with and without antifoam is c), where the data clearly shows that the inclusion of antifoam affected trinexapac-ethyl loss. Therefore, from the data, it is reasonable to expect that the inclusion of antifoam affects formulation stability.
Fourth, respectfully, this argument is not persuasive. Purely arguendo, the examiner notes that even if unexpected results were shown, the tested emulsifiers were tested in combination with a very specific combination of components, having a single concentration of each. Whether 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.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. See MPEP 716.02(d) I. While Applicant is not required to provide data for every embodiment which falls within the scope of the claims, Applicant has only provided a single data point for each emulsifier. To establish unexpected results over a claimed range, Applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See MPEP 716.02.
More specifically, the data of the instant specification only appears to test a single data point for each emulsifier, each comprising:
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From a single data point for each emulsifier in very specific concentration ratios, and in combination with a single specific concertation of condensation product of castor oil and ethylene oxide, dodecyl-benzene sulfonic acid calcium salt linear, antifoam, water, and pentanol mixture of isomers, it does not appear that the data could be reasonably extended to the full scope of the instant claims which recite open language and include any additional components, any concentration of PEO-PPO-PEO block copolymers that fall within the claimed range, and trinexapac-ethyl in any amounts. For example, the claims allow for even trace concentrations of trinexapac-ethyl and PEO-PPO-PEO block copolymers, where the skilled artisan would reasonably expect that the concentration of the active agent as well as the concentration of emulsifier would affect microemulsion properties and stability. From this, it does not appear that the data could be reasonably extended to the full scope of the instant claims.
Claims 3 and 17-19, stand rejected under 35 U.S.C. 103 as being unpatentable over Schlotterbeck et al (US 20110195839 A1, hereinafter “Schlotterbeck”), as applied to claims 1, 2, 4-9, 14-16, and 20 above, and further in view of Kober et al (US 20060100105 A1) and Wyandotte Chemicals (Chem Engin News Archive, 1961, vol 29, issue 50, pp. 1-4).
Schlotterbeck is discussed above but does not specifically teach a block copolymer with the molecular weights of claims 3 and 17-19.
Kober et al teach bioregulatory compositions used in plant cultivation, wherein the active agent may be trinexapac-ethyl (abs, ¶ 88). The compositions may be in the form of microemulsions (¶ 93). It was known to include PLURONIC polymers as surfactants of the type ABA with the formula R16O—(C2H4O)p—(C3H6O)q—(C2H4O)r—R17, wherein p, q, r independently of one another correspond to a value in the range of from 2 to 300, preferably from 5 to 200 and in particular from 10 to 150, and R16 and R17 independently of one another are hydrogen or C1-C4-alkyl, C1-C4-alkyl-CO, in particular methyl, t-butyl and acetyl, and further groups which are suitable for end capping (¶ 115).
Kober et al do not specifically teach an embodiment disclosing the molecular weight of the PEO block and the wt% of the PEO block as instantly claimed.
Wyandotte Chemicals teaches known PLURONIC polyols that are useful for agrochemical products as emulsifiers, emulsion stabilizers, and wetting agents, such as L84 (40% PEO, 2250 g/mol PPO), P85 (50% PEO, 2250 g/mol PPO), P94 (40% PEO, 2750 g/mol PPO), etc., where the particular PLURONIC polyols are selected based on their desired properties, such as good emulsifying properties, low foam, good wetting, soluble in cold water, etc. (Pluronic Grid, Example I).
Regarding claims 3, 17, and 19, where Schlotterbeck teaches propylene oxide/ethylene oxide block copolymers are suitable, including PLUROINC PE polymers, and Kober et al teach ABA PLURONIC polymers are suitable for microemulsions comprising trinexapac-ethyl, it would have been obvious to modify the microemulsion composition made obvious above by using other known PLURONIC polymers known to be suitable for agrochemical compositions, such as for example PLURONIC P94 (40% PEO, 2750 g/mol PPO), as taught by Wyandotte Chemicals, falling within the range of suitable PLURONIC polymers known for microemulsion compositions comprising trimaximal-ethyl, as taught by Kober et al. Further, it would have been well within the relative skills of the skilled artisan to determine the desired properties of the PLURONIC polymers in order to optimize the stability, wettability, solubility, etc., of the microemulsion composition made obvious above, by using the PLURONIC grid of Wyandotte Chemicals, which provides predictable properties of the PLURONIC polymers. See MPEP 2144(II)(A).
Regarding claim 18, it would have been obvious to modify the microemulsion composition made obvious above by using other known PLURONIC polymers known to be suitable for agrochemical compositions, such as for example PLURONIC L84 (40% PEO, 2250 g/mol PPO), as taught by Wyandotte Chemicals, for the same reasons discussed above. Further, it would have been well within the relative skills of the skilled artisan to determine the desired properties of the PLURONIC polymers in order to optimize the stability, wettability, solubility, etc., of the microemulsion composition made obvious above, by using the PLURONIC grid of Wyandotte Chemicals, which provides predictable properties of the PLURONIC polymers. See MPEP 2144(II)(A).
Response to Arguments
Applicants assert neither Kober nor Wyandotte Chemicals remedy the deficiencies of Schlotterbeck discussed above. Applicants assert neither reference provides a motivation to select the specific block copolymers with the claimed molecular weights and PEO weight percentages for use in trinexapac-ethyl emulsion. Applicants assert even if the skilled artisan were motivated, the skilled artisan would face an enormous number of possible PLURONIC polymer configurations.
Respectfully, this argument is not persuasive. Kober is directed to plant formulations that may comprise trinexapac-ethyl, where PLURONIC polymers of the ABA type overlapping the claimed range were known to be used for the same purpose, and where microemulsion formulations are also taught to be suitable. Likewise, Wyandotte Chemicals teaches PLURONIC polyols such as L84 (40% PEO, 2250 g/mol PPO), P85 (50% PEO, 2250 g/mol PPO), P94 (40% PEO, 2750 g/mol PPO), were known and useful emulsifiers for agrochemical formulations, where the particular selection is based on their desired properties, such as good emulsifying properties, low foam, good wetting, soluble in cold water, etc., which fall within the range of suitable polymers disclosed by Kober. Further, where Wyandotte Chemicals teaches the particular PLURONIC polyols can be selected based on desired properties, it would have been well within the relative skills of the skilled artisan to determine the desired properties of the PLURONIC polymers in order to optimize the stability, wettability, solubility, etc., of the microemulsion composition made obvious above, by using the PLURONIC grid of Wyandotte Chemicals, which provides predictable properties of the PLURONIC polymers, as discussed above. The prior art does not merely teach an unlimited number of unrelated compounds, rather, the prior art teaches a finite number PLURONIC polymers as suitable emulsifiers for emulsions and microemulsions, of which trinexapac-ethyl is taught as a suitable active, their selection being chosen based on their desired properties. From this, the skilled artisan would have been motivated select from disclosed alternatives in order to optimize formulation properties, etc.
Claims 4-7, and 9, stand rejected under 35 U.S.C. 103 as being unpatentable over Schlotterbeck et al (US 20110195839 A1, hereinafter “Schlotterbeck”), as applied to claims 1, 2, 4-9, 14-16, and 20 above, and further in view of Vogt et al (US 6071857).
Schlotterbeck is discussed above, and while appearing to teach concentrations of trinexapac ethyl, block copolymer, and solvent, falling within the instantly claimed concentration ranges, purely arguendo, if not, the following applies.
Vogt et al teach pesticidal compositions comprising a pesticide, such as trinexapac-ethyl and a block copolymer, wherein the compositions may be microemulsions (abs, col 3 ln 60, col 4 ln 2, examples 15 and 16, claims 23 and 31). The compositions have a total concentration of 1000 g/L (col 4 ln 5-6).
It would have been obvious to formulate the microemulsion composition made obvious by Schlotterbeck above, with a total concentration of 1000 g/L, which is known to be suitable for microemulsion compositions comprising trinexapac-ethyl, as taught by Vogt et al.
Regarding claims 4 and 5, upon formulating the microemulsion with a total concentration of 1000 g/L, the concentration of the nonionic surfactant at 0.5-30 wt%, as suggested by Schlotterbeck, results in a concentration range from 5-300 g/L, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been obvious for the skilled artisan to routinely adjust the amount of the nonionic surfactant in order to achieve optimal stability of the trinexapac ethyl microemulsion compositions made obvious above. See MPEP 2144.05(II)(A).
Regarding claims 6 and 7, upon formulating the microemulsion with a total concentration of 1000 g/L, the concentration of active agent, including trinexapac ethyl at 0.1-40 wt%, results in a concentration ranging from 10-400 g/l, overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been well within the relative skills of the skilled artisan to routinely adjust the amount of trinexapac ethyl in order to determine the optimal concentrations to achieve desired microemulsion composition activity for desired uses. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding claim 9, upon formulating the microemulsion with a total concentration of 1000 g/L, the concentration of solvent, each being in the range of 1-60 wt%, as suggested by Schlotterbeck, results in a concentration range from 10-600 g/l, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Further, it would have been obvious for the skilled artisan to routinely adjust the amount of the water miscible solvent in order to achieve optimal properties for the trinexapac ethyl microemulsion compositions made obvious above. See MPEP 2144.05(II)(A).
Response to Arguments
Applicants assert Vogt does not remedy the deficiencies of Schlotterbeck for the same reasons discussed above.
Respectfully, this argument is not persuasive. The claims stand rejected for the same reasons above and of record.
Claims 9 and 10 stand rejected under 35 U.S.C. 103 as being unpatentable over Schlotterbeck et al (US 20110195839 A1, hereinafter “Schlotterbeck”), as applied to claims 1, 2, 4-9, 14-16, and 20 above, and further in view of Windreich et al (WO 2015075646 A1).
Schlotterbeck is discussed above but do not specifically teach amyl alcohol. Further, purely arguendo, if somehow the concentration of solvent of Schlotterbeck does not fall within the claimed ranges of claim 9, the following also applies.
Windreich et al teach stable microemulsion formulations comprising trinexapac-ethyl, where it was known to include one or more solvents in a total amount of about 10 to about 80 wt% (abs, pg. 10 1st ¶, pg. 11 2nd ¶). Suitable solvents include water, amyl alcohol, etc. (pg. 11 1st ¶). Table 1 discloses a working embodiment, where a simple calculation reveals the total concentration of the formulation is 1840 g/L (table 1).
Regarding claim 9, it would have been obvious to modify the microemulsion composition made obvious above by Schlotterbeck by including solvents in known amounts taught to be suitable for microemulsion compositions comprising trinexapac-ethyl, such as from about 10 to about 80 wt%, as taught by Windreich et al. A simple calculation to convert wt% to g/L can be achieved by using the total concentration (1840 g/L) from the working embodiment of Windreich et al, where about 10 to about 80 wt% corresponds to about 184 to about 1472 g/L, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 10, it would have been obvious to include known solvents suitable for microemulsion compositions comprising trinexapac-ethyl, such as an amyl alcohol, as taught by Windreich et al.
Response to Arguments
Applicants assert Windreich does not remedy the deficiencies of Schlotterbeck for the same reasons discussed above.
Respectfully, this argument is not persuasive. The claims stand rejected for the same reasons above and of record.
Conclusion
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.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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