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 .
Claims 1-13 are pending in this application.
The disclosure is objected to because of the following informalities:
(1) Atlox® is misspelled as “Altlox®” on page 10, line 13.
(2) In Table 1 on page 32, propylene glycol is misspelled as “porpylene glycol.”
(3) Also in Table 1, Atlox® 4913 is shown to be present at >3.00% in SC1:
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However, experimental protocol disclosed on page 34 is inconsistent with Table 1, because Atlox® 4913 is disclosed as being present at “less than 3.00 w/w%” (page 34, lines 11-12):
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Appropriate corrections are required. Applicant is requested to check the accuracy of “>” in every table, for example, Table 2 also.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 9 recites “wherein said charged monomers comprise an anionic sulphate group” (emphasis added). The specification does not specifically disclose sulfate or sulphate group as the charged monomers. Rather, sulphonate group is disclosed as the charged monomers throughout the specification. Correction of claim 9 or amendment of the specification is required.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because “Use of” a substance as recited in claims 11 and 12 do not fall within at least one of the categories of patent eligible subject matter recited in 35 U.S.C. 101: process, machine, manufacture, or composition of matter.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
“Use of” of a substance as recited in claims 11 and 12 fails to recite a process step. It is therefore an incomplete process claim if that were the intended category of invention. The claim is indefinite for this reason.
Applicant is advised of the following regarding claims 11 and 12:
(1) These claims will not be further examined on the merits for the reasons set forth above. Claims drawn to a non-statutory category of invention cannot be examined on the merits.
(2) Claims 11 and 12 depend on the suspoemulsion composition of claim 1, which requires both a continuous liquid phase having a second active ingredient that is a solid suspended in the continuous phase and a liquid organic phase having a first active ingredient that is solubilized in the organic phase, wherein the organic phase is emulsified in the continuous aqueous phase. If claim 11 and/or claim 12 were properly amended to be directed to statutory subject matter, Applicant is given advance notice here that such claims may be found lacking unity of invention as failing to possess the same or corresponding special technical feature.
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.
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 1-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Steinbrenner et al. (WO 2021/175691; hereinafter, Steinbrenner) in view of Silbert et al. (WO 2017/098325; hereinafter, Silbert) and FAO Plant Production and Protection Paper 2281 (hereinafter, FAO Paper 228).
Steinbrenner (WO 2021/175691) discloses a stable aqueous suspoemulsion composition comprising a continuous aqueous phase, suspended solid phase, and dispersed oil phase, wherein
(1) the oil phase comprises an acetamide pesticide such as dimethenamid-P or
S-metolachlor (page 3, lines 6-9) and a solvent S1 that is not miscible with water such as a hydrocarbon or triglyceride such as vegetable oils, rapeseed oil, corn oil, soybean oil (paragraph bridging pages 3-4; page 4, lines 20-22), which dissolves the pesticide (page 2, lines 1-4; page 3, lines 11-12); wherein the solvent S1 can be 5-40 wt% of the final composition (claim 7) and the acetamide can be 10-600 g/l, 50-500 g/l or 100-400 g/l of the final composition (page 3, lines 14-15);
(2) the aqueous phase comprises mesotrione as suspended solid particles in water.
See claims 1-9; page 1, lines 24-25. Oil phase dimethenamid-P premix is shown to be emulsified in S1 (page 10, inventive example 1). Method of preparing the suspoemulsion is disclosed, wherein a suspension concentrate of mesotrione is added to a formulation of the acetamide dimethenamide-P and emulsified (page 9, line 18 to page 10, line 19; see also page 8, lines 1-7 and claim 10). Steinbrenner’s invention example 1 discloses 24.3 g oil phase + 15.9 aqueous phase, which is approximately a 1.5:1 weight ratio. Steinbrenner discloses suspoemulsion as “typically a conventional type of formulation” (page 1, lines 34-37). Steinbrenner’s suspoemulsion “typically comprise one or more emulsifiers or surfactants to emulsify and stabilize the oil phase in the aqueous phase” (page 4, lines 30-31). Suitable surfactants include block polymers, polyelectrolytes, which are used as for example emulsifier, dispersant (page 5, lines 7-10). Storage stability and no phase separation or agglomeration is disclosed (page 9, lines 7-10).
Silbert (WO 2017/098325) discloses an agricultural composition comprising particles of at least one agricultural compound, e.g., herbicide, and a polyelectrolyte block copolymer as a dispersant or emulsifier, which block copolymer is adsorbed on the hydrophobic surfaces of the pesticide particles and stabilizes dispersions (page 5, lines 2-19; page 6, lines 11-22; page 15, lines 11-19; page 16, lines 2-3; claims 38-39, 50). The particles can be solid, liquid, or dissolved in solvent (page 17, line 1 to page 18, line 5). The composition can be an emulsion (e.g., oil in water emulsion; Example 6 on page 61), suspension concentrate, or a “suspo-emulsion” (page 18, line 23 to page 19, line 20). The polyelectrolyte block copolymer can comprise at least 60% at least one anionic monomer such as AMPS, i.e., 2-acrylamido-2-methylpropane sulfonate and a hydrophobic moiety (page 31, line 25 to page 33, line 30; page 34, last paragraph; page 37, lines 7-13). PolyAgro A (77% AMPS) and PolyAgro B (69% AMPS) are disclosed as suitable polyelectrolyte block copolymers (Example 1 on pages 46-48; Example 5 on pages 57-59). Silbert also discloses that sulfate polyelectrolytes are known (page 3, lines 20-31, lines 26-27 in particular). Based on the total weight of the composition, the polyelectrolyte block copolymer can be present in about 0.1-3 wt% (page 35, lines 8-11). Combination of 1.28 wt% PolyAgro A and 1.45 wt% AtloxTM 4913 (polymethyl methacrylate-polyethylene glycol graft copolymer) is disclosed (page 50).
FAO Paper 228 establishes that suspo-emulsion is a known formulation type for pesticides, wherein the formulation is a mixture of water-insoluble active ingredients dispersed in an aqueous solution, where one or more active ingredient is in suspension form and one or more active ingredient is in emulsion form (page 183).
Steinbrenner does not explicitly disclose the polyanionic block copolymer surfactant of the instant invention. However, Silbert teaches the same polyanionic block copolymer for suspoemulsions at substantially similar amounts, wherein said copolymer has the functionality to be adsorbed on the hydrophobic surfaces of the pesticide particles and stabilizes dispersions. Silbert further teaches the combined use with AtloxTM 4913, which is a polymethyl methacrylate-polyethylene glycol graft copolymer.
Thus, the ordinary skilled artisan would have found it obvious to formulate a herbicidal suspoemulsion of mesotrione and acetamide such as dimethenamid-P or S-metolachlor by using Silber’s polyanionic block copolymer such as PolyAgro A, which is 77% AMPS in combination with the polymer AtloxTM 4913 to obtain a stabilized dispersion.
Specification results have been given due consideration in this regard, but it is noted that SE3 (comparative) in Table 2 has propylene glycol + additional anionic surfactant, whereas SE4 (invention) has polyvinyl alcohol, which is not even recited in the instant claims. Atlox 4913 is disclosed as >0.50 wt% for SE3, so that ingredient cannot be relied upon as the difference between SE3 and SE4, which has 1 wt% Atlox 4913. Hence, the only difference that can be assigned is propylene glycol + anionic surfactant vs. PVA. A composition comprising all the ingredients of SE4 is not presented in any of the claims. Therefore, the evidence presented in the specification is extremely narrow and falls far short of being commensurate in scope with that of the claims.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited references.
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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/553,409 (reference application) in view of Steinbrenner et al. (WO 2021/175691), Silbert, and FAO Paper 2282.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Claims 1-7 of the reference application are directed to a suspoemulsion comprising (i) an aqueous phase; (ii) liquid organic phase emulsified in the aqueous phase, the liquid organic phase comprising at least one lipophilic active ingredient and optionally a lipophilic organic solvent; (iii) at least 5 wt% salt, (iv) thickener, (v) a combination of surfactant comprising 0.1-15 wt% of a polyanionic block copolymer surfactant that is the same as the polyanionic block copolymer of the instant application claims, and a second surfactant, and (vi) a solid active ingredient.
Teachings of Steinbrenner et al. (WO 2021/175691), Silbert, and FAO Paper 228 were discussed above in the previous ground of rejection, and the discussions there are incorporated herein by reference.
The claims of the reference application do not explicitly disclose the active ingredient in (ii) as solubilized in the organic phase. However, Steinbrenner teaches the same organic solvents for dissolving active ingredient in the organic phase of a suspoemulsion formulation.
The claims of the reference application do not explicitly disclose the solid active ingredient of (vi) as suspended in the continuous aqueous phase. Steinbrenner teaches the aqueous phase to comprise mesotrione as suspended solid particles in water.
Silbert further teaches the combined use with AtloxTM 4913, which is a polymethyl methacrylate-polyethylene glycol graft copolymer with a polyanionic block copolymer of the claimed invention.
The claims of the reference application do not explicitly disclose a preparation method wherein an oil in water emulsion is mixed with an aqueous suspension in a 10:1 to 1:10 ratio. However, suspoemulsion is a known mixture of suspension concentrate and oil in water emulsion; and Steinbrenner’s invention example 1 discloses a 1.5:1 weight ratio mixture of oil phase and aqueous phase, which is suggestive of the claimed ratio.
For these reasons, the ordinary skilled artisan would have recognized that the claimed invention is an obvious variation of the invention set forth in the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699
ODP 18/553,409
ODP 18/713,991
1 Cited in attached PTO-892, non-patent document U.
2 Cited in attached PTO-892, non-patent document U.
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