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 .
Response to Amendment
The Amendment filed 12/05/2025 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 09/05/2025. Applicant’s claims have been amended in the following manner: independent claim 1 has been modified by inclusion of limitations (i) and (ii) (related limitations previously found in claim 97, but also support found in Applicant’s Specification), which in combination with the arguments is persuasive to withdraw the 103 rejection. Amendment has occurred for the 112b rejection for “derivatives” in claims 8 and 19 and the “and/or” objection of claim 19. Other minor amendments are noted. Note that claim 97 is no longer a “new” claim. The following objections/rejections are withdrawn: 112a, 112b, and 103 rejections, and the claim objections.
Note the provisional ODP rejection has been modified to a non-provisional ODP rejection to accurately reflect the state of the Application, because the copending application 17/291,042 was granted as Patent US12414559B2 (see below). Note the restriction requirement is maintained, because the double patenting rejection is still maintained.
The Examiner further acknowledges the following:
Claims 1-2, 8, 19, 29, 63-66, 69, 71-72, 81-85, 93, and 96-97 are pending.
Claims 63-66, 69, 71-72, 81-85, 93, and 96 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-2, 8, 19, 29, and 97 are presented for examination and rejected as set forth below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-2, 8, 19, 28, and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over, and in further view of Grabarnick (WO2019038583A1), Mayer (WO2015007573A1), Brown (US20150342180A1), and Fowler (US20080248955A1).
claims 1-20 of Patent No. US12414559B2 (formerly copending application 17/291,042 (as found in the previous Non-Final Office Action)
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach 5- fluoro-4-imino-3-methyl-l-tosyl-3-dihydropyrimidin-2(1H)-one pesticide formulations, including the instant claim 1 (i) pH limitation and (ii) water limitation. Patent ‘559 differs only significantly by not including the (iii) specified anhydrous polymorph form 1 of 5- fluoro-4-imino-3-methyl-l-tosyl-3-dihydropyrimidin-2(1H)-one and additional formulation limitations found in the instant claim set (that were demonstrated obvious in the previous Non-Final Action).
This is remedied by the additional references, who teach these elements as disclosed in the 103 rejection, using the same rationale and motivations (see obviousness rationale from previous Non-Final Rejection filed 09/05/2025). Notably, Grabarnick provides motivation for use of the anhydrous crystalline form 1 (i.e., instant claim 1(iii)) (as a specific version of the more broadly taught compound of claim 1 in Patent ‘559), in that it is a stable form that is more easily formulated for agricultural use, as far as milling/granulation (pg 55, Grabarnick – claim 6).
This is a non-provisional rejection because the Patent has now been issued for the previously discussed copending application.
Response to Arguments
Applicants arguments, see pg 1-8, filed 12/5/2025, with respect to the 103 rejection of claims 1-2, 8, 19, 29, and 97 under rejection have been fully considered and are persuasive.
On page 1-2, Applicant again traverses the restriction requirement. The Examiner reiterates the previous argument in the Non-Final Action (filed 09/05/2025). More specifically, Applicant argues that a PHOSITA “would not be able to assume that Form I polymorphs would have greater than 95% of more purity of the Form I polymorph.” The Examiner disagrees that when a reference declares a compound as a Form I polymorph with xrpd evidence (Grabarnick – claim 6, Table 1), a PHOSITA would understand about 100% Form I as the base case, unless corrected otherwise. Furthermore, Grabarnick teaches several methods for preparing Form I in pure form in Example 1 (pg 43-46) and provides analytical data demonstrating pure (100%) Form I (pg 45-46 references Figure 10 by DSC and pg 52 discuss Form I by XRPD). Thus, the arguments are not persuasive and the restriction is maintained.
On page 2-3, Applicant discusses amendments made to overcome the claim objections and 112 a/b rejections, which are found persuasive. Thus, the objections and 112 a/b rejections are withdrawn.
On page 3-6, Applicant restates the Office’s position and replies (with the main arguments focused around unexpected results). Applicant’s arguments are persuasive against the 103 rejection (but not the double patenting rejection; see further below), and are summarized below.
Regarding the unexpected results that support the limitation of instant claim 1(i): Figure 11 demonstrates the dependence of active compound (i.e., Formula I) stability in relation to water content of the formulation at accelerated stability conditions (2 weeks at 54 C). The Prior Art does not reasonably predict this stabilizing effect for the specified compound. As the result of Figure 11 demonstrates a general instability of the compound with trace water in non-aqueous formulations, the extrapolation of this result to the instant non-aqueous formulations is reasonable.
Although Fowler demonstrates the obviousness of maintaining agrochemical formulations where the emulsifiable concentrate has less than 2 wt% water [0023] for the purpose of active ingredient stability [0094], the Examiner recognizes this pertains to an active ingredient unrelated in structure to the instant compound (i.e., clodinofop-propargyl and cloquintocet-mexyl, where the ester group is likely sensitive to hydrolysis compared to instant compound formula I that has a completely unrelated structure, and thus the stability of this compound under different water content levels is not reasonably predictable). Furthermore, although it does not inform on further restricting the water content limitation explicitly to <0.5 wt%, a PHOSITA would recognize that lower amounts of water (i.e., approaching 0%) would be preferable in the formulation because water affects active ingredient stability [0023, 0097].
Regarding the unexpected results that support the limitation of instant claim 1(ii): Example 1 (pg 162-165; 450 SC @ pH 6-6.6 is an aqueous suspension) demonstrates less than 5% decomposition after 2 weeks at 54 C; by contrast, Example 9 (pg 181-182 of the Specification; compositions @ pH 4 or pH 8 are aqueous suspensions) demonstrate significant degradation of the active compound, where Applicant states that by contrast, the aqueous compositions are more stable from pH 5-7.5 (as also limited by instant claim 1(b)(i)) and a comparison of Example 1 and Example 9 show similar compositional makeup (i.e., they both contain: compound of Formula I, Supragil WP, Soprophor 3D33, Soprophor TS/54, SAG 1572, xanthan gum, propanediol/propylene glycol, base, acid, etc.). The Prior Art does not reasonably predict this stabilizing effect of pH for the specified compound. As the result of Examples 1 and 9 demonstrate pH dependence to be a critical factor in stability of the instant compound of Formula I within an aqueous formulation, a PHOSITA would expect the same stabilizing effect across other similarly aqueous formulations discussed by the instant application.
Although Fowler demonstrates the obviousness of maintaining agrochemical formulations within a pH range of 5-7 [0022, 0097], with water-miscible polar aprotic solvents [0009] (i.e., Table 2 incorporates Exxate 800 which is composed of alkyl esters of acetic acid [0078] and acetophenone into formulations), to stabilize the active ingredient of the formulation, the Examiner recognizes this pertains to an active ingredient unrelated in structure to the instant compound (i.e., clodinofop-propargyl and cloquintocet-mexyl, where the ester group is likely sensitive to hydrolysis compared to instant compound formula I that has a completely unrelated structure, and thus the stability of this compound under different pH is not reasonably predictable).
Therefore, the unexpected results support the limitations of instant claims 1(i) and 1(ii) (including the other independent claims of the claim set that maintain this requirement), and are commensurate in scope of the claim set under examination (excluding consideration of the withdrawn claims). Note that the liquid carrier can either be aqueous or non-aqueous, and thus, the combination of (i) and (ii) in claim 1 constitutes a complete scope of the liquid carrier.
On page 6-7, Applicant argues the obviousness double patenting rejections. However, the modification of Patent No. US12414559B2 (formerly copending application 17/291,042 in the discussion of Non-Final Office Action (filed 09/05/2023)) still stands, because Grabarnick provides motivation for use of the anhydrous crystalline form 1 (i.e., the differing aspect between claim sets, exhibited by instant claim 1(iii)), in that it is a stable form that is more easily formulated for agricultural use, via milling/granulation (pg 55)).
Furthermore, Applicant has not provided persuasive arguments/data that demonstrate an unexpected improvement of the more broadly framed US12414559B2 (i.e., compared to the instant application that narrows according to anhydrous crystalline Form I, as the major difference). Applicant may support future arguments by filing an eTD or providing arguments/data (i.e., Specification, Affidavit, or Declaration).
Note there was a brief telephone communication with Applicant, regarding filing procedures around the above ODP issue. While acknowledgement is made of Applicant’s proposed discussion around claims 63, 66, and 71 (and their dependent claims), because the ODP is maintained, the restriction requirement has not yet been withdrawn.
On page 8, Applicant concludes.
Correspondence
Applicant's amendment necessitated the new ground 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 extension fee 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 date of this final action.
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/R.P./Examiner, Art Unit 1614 2/4/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614