DETAILED ACTION
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
Claims 1 and 4-6 are pending.
Withdrawn Rejections
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn.
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 1 and 4-6 are rejected under 35 U.S.C. 103 as being obvious over Teranishi et al. (WO 2021/085389 A1; English-language equivalent US 2024/0114908 A1 referred to herein).
The applied reference has a common assignee and inventors with the instant application. Based upon the earlier effectively filed date of the reference, 18 October 2019, it constitutes prior art under 35 U.S.C. 102(a)(2).
Teranishi et al. teach throughout the reference an agricultural and horticultural fungicide compositions comprising a 2,6-dioxo-3,6-dihydropyrimidine compound and may contain other ingredients including a fungicide, an insecticide/acaricide, a nematicide, a soil pesticide, a plant regulator, a synergist, a fertilizer, a soil conditioner, and an animal feed (Abstract; [0001], [0006], [0023], [0076]-[0078], [0658]-[0660], [0710], [0788], etc.; Claims 2, 5-8).
Regarding claim 1, Teranishi et al. teach compounds of formula (I)
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wherein the substituents A, Q and X1-X3 overlap with the instantly claimed compounds ([0007]-[0023], [0081], [0900]-[0901], [0904]-[0905]; Tables 2-3, 6-7; Claim 2). Teranishi et al. specifically teach compounds such as:
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([0859], [0873]; Table 2, A-17 to A-19; Table 3, A-41 to A-42, A-57, and many others).
Teranishi et al. do not explicitly disclose compositions comprising a compound of formula (I) and at least one additional compound selected from the group consisting of thiophanate-methyl, triflumizole, cyflufenamid, iminoctadine acetate, iminoctadine albesilate, picarbutrazox, ipflufenoquin, fluxapyroxad, cymoxanil, tebufenozide, prothioconazole, mefentrifluconazole, potassium phosphite, florylpicoxamid, metyltetraprole, captan, fipronil, fludioxonil, chlorantraniliprole, fluopyram, abamectin, sulfoxaflor, Bacillus subtilis, Pseudomonas rhodesiae, sodium hydrogen carbonate, potassium bicarbonate, orange oil, linalool, thymol, neem oil, mancozeb, and mineral oils, as recited in instant claim 1.
However, Teranishi et al. teach that the compositions may contain other ingredients including a fungicide, an insecticide/acaricide, a nematicide, a soil pesticide, a plant regulator, a synergist, a fertilizer, a soil conditioner, and an animal feed ( [0658]-[0660], [0710], [0788], etc.). Teranishi et al. teach that the additional fungicides include thiophanate methyl ([0667]), triflumizole ([0692]), abamectin ([0728]), etc. Teranishi et al. further teach that containing such other ingredients may cause a synergistic effect ([0658]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to Teranishi et al. comprising a compound of formula (I) and at least one component selected from the group consisting of a fungicide, an insecticide/acaricide, a nematicide, a soil pesticide, a plant regulator, a synergist, a fertilizer, a soil conditioner, and an animal feed. A person of ordinary skill in the art would have been motivated to select thiophanate methyl, triflumizole, abamectin, and others as the additional fungicide, with the reasonable expectation that the combination would be fungicidally effective and may exhibit synergism.
Regarding claim 4, Teranishi et al. teach that the agricultural and horticultural fungicide of the present invention contains at least one selected from the compound (II) and a salt thereof as an active ingredient. The amount of the compound (II) or a salt thereof included in the agricultural and horticultural fungicide of the present invention is not particularly limited as long as it shows the bactericidal effect ([0586], [0635], [0801]). Teranishi et al. teach that additional examples of the other ingredients can include a fungicide, an insecticide/acaricide, a nematicide, a soil pesticide, a plant regulator, a synergist, a fertilizer, a soil conditioner, and an animal feed that are conventionally known ([0658]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to determine through routine experimentation the effective ratio of the compound of formula (I) and at least one additional compound to control fungi, insects, acaricides and nematicides, as reasonably suggested by Teranishi et al.
Regarding claims 5-6, Teranishi et al. teach the fungicide is for seed treatment ([0049], [0656]-[0657], [0913], [0916], [0919], etc.; Claim 6).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Response to Arguments
Applicant's arguments filed 11 May 2026 have been fully considered but they are not persuasive. Applicant argues that the instantly claimed combination of a compound of formula (I) and at least one compound selected from the group listed exhibits synergistic results. These results for this combination of compounds are not in any way suggested by the disclosure of Teranishi et al.
The examiner respectfully argues that the data in Tables 3-12 of the instant specification are not commensurate in scope with the instant claims. The compounds of formula (I) recited in Tables 3-12 all share common structural features, such as R1 is isopropyl; R6 is H or CH3; X3 is -CH2-CH(CH3 or isopropyl)-NH-CO-isopropyl or tert-butyl; A is -CH2CHOH- or CH2CH(OCH2CN); and Q is 2-methoxyphenyl or 2-methoxy-5-fluorophenyl. Therefore, the substituents at these positions are structurally similar and have minor differences. However, the instant claims include a large number of varying substituents at the positions R1, X3, A and Q that are not structurally similar to the compounds in Tables 3-12. Thus, the limited number of species tested in Tables 3-12 of the instant specification is not a representative number of species for the entire genus of compounds instantly claimed.
Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Bantle et al. (EP 0 748 800 A2).
Bantle et al. teach throughout the reference α1-adrenergic receptor antagonists of formula I useful for the treatment of diseases involving directly or indirectly an obstruction of the lower urinary tract (Abstract; Claims 1-23).
Regarding claim 1, Bantle et al. teach that the compound of formula I includes 1-benzyl-3-{3-[4-(2-methoxyphenyl)piperazin-1-yl]propyl}-5-hydroxyiminomethyl-2,4(1H,3H)-pyrimidinedione (pg. 39, Example 31):
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Bantle et al. do not explicitly disclose compositions comprising the compound of formula I and at least one other component selected from the group consisting of thiophanate-methyl, triflumizole, cyflufenamid, iminoctadine acetate, iminoctadine albesilate, picarbutrazox, ipflufenoquin, fluxapyroxad, cymoxanil, tebufenozide, prothioconazole, mefentrifluconazole, potassium phosphite, florylpicoxamid, metyltetraprole, captan, fipronil, fludioxonil, chlorantraniliprole, fluopyram, abamectin, sulfoxaflor, Bacillus subtilis, Pseudomonas rhodesiae, sodium hydrogen carbonate, potassium bicarbonate, orange oil, linalool, thymol, neem oil, mancozeb, and mineral oils, as recited in instant claim 1.
However, Bantle et al. teach that the compounds of Formula I will be administered as pharmaceutical compositions and are comprised of, in general, a compound of Formula I in combination with at least one pharmaceutically acceptable excipient, such as mineral oil (pg. 7, ln. 15-28).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to Bantle et al. comprising a compound of formula I, such as the compound of Example 31, and a liquid excipient, such as mineral oil. Such would have been obvious because Bantle et al. teach that compounds of formula I specifically include 1-benzyl-3-{3-[4-(2-methoxyphenyl)piperazin-1-yl]propyl}-5-hydroxyiminomethyl-2,4(1H,3H)-pyrimidinedione (Example 31), and the compounds of Formula I will be administered as pharmaceutical compositions in combination with at least one pharmaceutically acceptable excipient. Acceptable excipients are non-toxic, aid administration, and do not adversely affect the therapeutic benefit of the compound of Formula I. Such excipient may be any solid, liquid, semisolid or, in the case of an aerosol composition, gaseous excipient that is generally available to one of skill in the art. Liquid and semisolid excipients include mineral oil (pg. 7, ln. 15-26).
Regarding claim 4, Bantle et al. teach that the amount of a compound of Formula I in the composition may vary widely depending upon the type of formulation, size of a unit dosage, kind of excipients and other factors known to those of skill in the art of pharmaceutical sciences. In general, the final composition will comprise from 0.000001%w to 10.0%w of the compound of Formula I, preferably 0.00001%w to 1.0%w, with the remainder being the excipient or excipients (pg. 7, ln. 33-36).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to determine through routine experimentation the effective ratio of the compound of formula (I) and excipients, as reasonably suggested by Bantle et al.
The examiner respectfully points out the following from MPEP 2144.05: “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed.Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Response to Arguments
Applicant's arguments are the same as above. Therefore, the examiner’s response above is repeated here as well.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 4-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 of copending Application No. 17/767,749 in view of Harriman et al. (WO 2013/071169 A1).
The instant claims and the ‘749 Application both claim an agricultural and horticultural fungicide composition comprising a 2,6-dioxo-3,6-dihydropyrimide compound as the active ingredient. The ‘749 Application claims a compound according to formula (I):
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wherein the substituents for A, Q and X1-X3 are the same as or overlap with the corresponding substituents in the instant claims.
The ‘749 Application does not claim at least one additional active component selected from the group consisting of the compounds instantly claimed.
Harriman et al. teach thienopyrimidine derivatives of formula (I) that are useful as fungicides ([00205]-[00209]). The thienopyrimidine derivatives are structurally similar to the instantly claimed compounds, wherein the pyrimidine ring of the instant claims is replaced with a thienopyrimidine ring. Harriman et al. teach that the compositions according to the invention can, in the use form as fungicides, also be present together with other active substances, e.g. with herbicides, insecticides, growth regulators, fungicides or else with fertilizers, as pre-mix or, if appropriate, not until immediately prior to use (tank mix). Examples of other active substances include triflumizol, cyflufenamid, iminoctadine, iminoctadine-triacetate, iminoctadine-tris(albesilate), cymoxanil, prothioconazole, mancozeb, and others ([0243], [0246], [0261], [0263]-[0264]). Mixing the compounds of formula I or the compositions comprising them in the use form as fungicides with other fungicides results in many cases in an expansion of the fungicidal spectrum of activity being obtained or in a prevention of fungicide resistance development. Furthermore, in many cases, synergistic effects are obtained ([00238]-[00239]).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare compositions according to the ‘749 Application claims further comprising an additional active such as those instantly claimed in order to expand the fungicidal spectrum of activity being obtained or in a prevent fungicide resistance development, and possibly obtain synergistic effects, as reasonably suggested by Harriman et al.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments are the same as above. Therefore, the examiner’s response above is repeated here as well.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571) 272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.W.S/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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