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 .
The Applicants’ Amendment to the Claims filed on October 23, 2025 is entered.
Claims 6-7, and 15 are cancelled.
Claims 16-23 are new.
Claims 1-5, 8-14, and 16-23 are pending and under examination.
Priority
This US Application 18/000,576 is a 371 of PCT/EP2021/064712 filed on 06/01/2021 which claims foreign priority benefit of EP 20178367.7 filed on 06/04/2020.
Information Disclosure Statement
The IDS filed on filed on 07/21/2025 and 10/23/2025 has been considered by the examiner.
Response to Amendment
The rejections of claim 15 under 35 U.S.C. 101, 35 U.S.C. 112(b), and 35 U.S.C. 103 are rendered moot as claim 15 is presently cancelled.
The rejection of claims 2, 3 and 5 under 35 U.S.C. 112(b) is withdrawn in view of the Applicants’ Amendment to the Claims filed on October 23, 2025.
Rejections of cancelled claims 6-7 are rendered moot.
Claim Rejections - 35 USC § 112
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.
Newly added claims 20 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. This is a new grounds of rejection.
New claim 20 is indefinite because it lacks a period at the end of the claim.
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
New claim 23 is 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 23 recites the composition according to claim 1, wherein the weight ratio of (A) to (B) is synergistic as calculated by the Colby formula. However, the instant specification and state of the art does not provide a representative set of compositions according to claim 1 wherein the weight ratio of (A) to (B) is synergistic as calculated by the Colby formula so that one of ordinary skill in the art would be able to envision whether a given composition encompassed by the claims would posses the required property of being synergistic as calculated by the Colby formula.
The Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as be structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXlS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original).
To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these.
While having written description for the ratio amounts shown in Tables 1-5, in pages 40-42 of the instant specification, where component A is Aureobasidin A as component (A) and component (B) is either of components: difenoconazole, mefentrifluconazole, imazalil or fenhexamid, the specification does not provide sufficient descriptive support for the myriad of embodiments embraced by the claims regarding component (A). When there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Given this lack of description of representative species encompassed by the genus of the claim, the specification does not sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the entire scope of the claimed invention.
Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. However, if a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, first paragraph. Adequate written description requires more than a mere statement that a compound is part of the invention and reference to a potential method of isolating a compound. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
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.
Claims 1-5, 8-14, and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Ring et al (WO2018/102345, of record; as evidenced by STIC Structure Search result; of record), in view of Schwarz et al (US2016/0326140 published 11/10/2016; of record), in view of Fujikawa et al (J Org Chem, 1994, 59, 570-578).
Regarding currently amended claim 1, Ring et al disclose a fungicidal composition comprising a mixture comprising component (A) cyclic depsipeptide Aureobasidin (which is of formula (I-A1) as an active ingredient for the use of treatment of fungal infections. Ring et al disclose a composition comprising component (A) being Aureobasidin A of structure A-1 and at least a second antifungal active component (See page 3, lines 24-28; STIC Structure Search results for WO2018/102345 to Ring et al.)
Ring et al discloses the use of Aureobasidin A in combination with other active agents for the treatment of fungal infections. For example, both Aureobasidin A and azoxystrobin are fungicides.
Regarding claims 2, 16-20, and 21-23, Ring et al discloses that the active ingredient is present from 0.1 to 95% by weight (page 4, line 5). Although Ring et al does not explicitly discloses that the weight ratio of (A) to (B) is from 100:1 to 1:1000, it is considered that the active ingredient present from 0.1 to 95% by weight renders obvious the range of weight ratio of (A) to (B) is from 100:1 to 1:1000. For example, 50% by weight of each active ingredient would be a 1:1 ratio which is encompassed by the claimed range. Regarding new claims 18-21, the ranges of 20% to 99.9%, 40% to 99.9%, and 0.1% to 80%, and 0.1% to 60% are encompassed by the prior art range of 0.1 to 95% by weight.
It would have then been obvious to vary the amount of each component based on the desired impact, i.e. providing antifungal properties, where the primary reference discloses a broad range of active as well as a broad range of application concentrations.
One of ordinary skill in the art would have been motivated to combine them for the rationale of increasing effectiveness as a fungicide. Regarding new claim 16 a 1:1 ratio is encompassed by the claimed range of (A) to (B) from 100:1 to 1:500. Regarding new claim 17 a 1:1 ratio is encompassed by the claimed range of from 50:1 to 1:200. Regarding new claim 22 a 1:1 ratio is encompassed by the claimed range of (A) to (B) from 20:1 to 1:20.
Further, regarding claim 5, Ring et al differs in they do not explicitly disclose that component (A) comprises: from 10% to 99.9% by weight of a cyclic depsipeptide of formula (I-A1) or a stereoisomer thereof, and from 0.1% to 90% by weight of one or more other cyclic depsipeptides of formula (I-A) or stereoisomers thereof. However, Ring et al discloses that the active ingredient is present from 0.1 to 95% by weight (page 4, line 5). Ring et al discloses that the aureobasidins are active ingredients. Thus it is considered prima facie obvious that the aureobasidins would be present from 0.1 to 95% by weight (page 4, line 5) because Ring et al disclose this range for aureobasin. It would have then been obvious to vary the amount of each component based on the desired impact, i.e. providing antifungal properties, where the primary reference discloses a broad range of active as well as a broad range of application concentrations. One of ordinary skill in the art would have been motivated to combine them for the rationale of increasing effectiveness as a fungicide.
Regarding claim 8, Ring et al discloses an agriculturally acceptable carrier and/or formulation adjuvant. (See page 3, lines 10-17.)
Regarding claim 9, Ring et al disclose the use of Aureobasidin in the treatment of fungal infections. Ring et al is entitled: “Use of the Antifungal Aureobasidin A in Agriculture”. Ring et al disclose applying the fungicides to crop plants. Ring et al disclose applying the fungicide containing compositions to crop plants. Ring et al disclose that such fungal infections include Magnaporthae oryzae, Alternaria solani, Septoria tritcum, Fusarium oxysporum, Rhizochotonia soani.
Regarding claim 10, Ring disclose that application may vary from 2-1000g per acre (pg 4 lines 18- 23). Further, the phrase “the component (A) is applied at a rate of from 25 g a.i./ha to 500 g a.i./ha in association with 25 g a.i./ha to 500 g a.i./ha of component (B)” is unclear and renders the claim indefinite. The instant specification does not disclose the units recited in the claim. However, it is known in the pesticide art that "g a.i./ha" in the context of pesticides refers to grams of active ingredient per hectare. It indicates the amount of the actual pesticide chemical (the active ingredient) that is applied to a specific area, in this case, one hectare (10,000 square meters). Note that ha stands for hectare, which is about 2.47 acres. Ring et al disclose application is taught to vary from 2-1000g per acre which renders obvious 25 to 500 grams per hectare (2.47 acres) (pg 4 lines 18- 23). Note that Ring et al disclose a combination of active ingredients and it is considered that it would have been prima facie obvious to apply a range of from 25 g to 500 g of each of the active ingredients because Ring et al disclose application of active ingredient is taught to vary from 2-1000g per acre which renders obvious 25 to 500 grams per hectare (2.47 acres) (pg 4 lines 18- 23)..
Regarding claim 11, Ring et al discloses that the phytophathogenic fungi include Alternaria, and Septoria for use for crop plants. (See page 2, lines 11-31.)
Regarding claim 12, Ring et al discloses the fungus are taught to impact known plants, from wheat to fruits and berries (pg 5 lines 8-11, 24-35).
Regarding claim 13, Ring et al discloses the crops include soybeans. (See page 5, line 28.)
Regarding claim 14, Ring et al discloses that the phytophathogenic fungi include Alternaria, and Septoria for use for crop plants including soybean plants. (See page 2, lines 11-31.)
Further, regarding claims 3-4, Ring et al teaches Aureobasidin A but does not specify Aureobasidin E and Aureobasidin G as the additional one or more other cyclic depsipeptides of formula (I-A) or stereoisomers thereof. (See page 1, lines 29-30).
Fujikawa et al teaches aureobasidin E was a known depsipeptide with potent antifungal activity (abstract).
Further, Ring et al does not disclose the component (B) is difenoconazole, imazalil, or fenhexamid.
Schwarz et al disclose difenoconazole, imazalil, and fenhexamid. (See para 0605). Schwarz et al disclose pesticide compositions for controlling pests on crop plants. (See Abstract, Title, para 0625-0627.) Schwarz et al disclose mixtures comprising fungicides and pesticides. (See para 0571). Schwarz et al include cyclic depsipeptides in their pesticide compositions. (para 0686). Schwarz et al disclose combination of active ingredients are beneficial for the following reasons:
[0571] The compounds of the formula (I) can also be used in a mixture with one or more suitable fungicides, bactericides, acaricides, molluscicides, nematicides, insecticides, microbiological agents, beneficial organisms, herbicides, fertilizers, bird repellents, phytotonics, sterilants, safeners, semiochemicals and/or plant growth regulators, in order thus, for example, to broaden the spectrum of action, prolong the period of action, enhance the rate of action, prevent repellency or prevent evolution of resistance. In addition, active ingredient combinations of this kind can improve plant growth and/or tolerance to abiotic factors, for example high or low temperatures, to drought or to elevated water content or soil salinity. It is also possible to improve flowering and fruiting performance, optimize germination capacity and root development, facilitate harvesting and improve yields, influence maturation, improve the quality and/or the nutritional value of the harvested products, prolong storage life and/or improve the processability of the harvested products.
One of ordinary skill in the art would have been motivated to have combined the antifungal agents including aureobasidin E of Fujikawa et al in order to provide a new antifungal composition useful for the same purpose (providing antifungal properties to crops). This position is consistent with well-established precedent holding that it is prima facie obvious to combine compositions known to be individually useful together so as to provide a third composition for the same use, treatment of the fungus on the plants taught by the references. See MPEP 20144.06(I).
It would have been obvious to modify the invention of Ring et al to further include the compounds of Schwarz et al for the rationale of Schwarz et al to broaden the spectrum of action, prolong the period of action, enhance the rate of action, prevent repellency or prevent evolution of resistance. In addition, active ingredient combinations of this kind can improve plant growth and/or tolerance to abiotic factors, for example high or low temperatures, to drought or to elevated water content or soil salinity, as shown in para 0571 just above.
One of ordinary skill in the art would have been motivated to have combined the antifungal active ingredient agents in a composition with the pesticidal agents because Schwarz et al explicitly suggests doing such. Further, it would have been obvious to do such because each were successfully used as fungicides/pesticides before the effective filing date of the presently claimed invention. Ring et al discloses that the composition is effective at controlling fungal infections on plant and seeds. Ring et al teach that the composition is effective in a method of controlling fungal infections (Alternaria and Septoria) on plants and seeds.”
In view of the high skill level in the art it is considered that one of ordinary skill in the art having the cited references before the effective filing date of the presently claimed invention would have had a reasonable expectation of success combining the known compounds of the cited references for use applying as a fungicide to a variety of plants including crop plants.
Thus the claims as a whole are rendered obvious over the cited reference.
Response to Arguments
The applicants’ response filed on 10/23/2025 has been fully considered but is unpersuasive. The applicants argue that the applied art fails to render obvious a fungicidal composition comprising a mixture of components (A) and (B) as active ingredients, where component (A) comprises a cyclic depsipeptide of formula (I-A1) or a stereoisomer thereof; and component (B) being selected from difenoconazole, mefentrifluconazole, imazalil and fenhexamid. The applicants argue that “the applied art fails to support the rejection as presented. Further, the applicants argue that to “the extent Schwarz discloses cyclic depsipeptides as a potential mixing partner to the pesticidal compounds disclosed therein, those cyclic depsipeptides are distinct from those Ring”. The applicants continue that in Schwarz the cyclic depsipeptides are for ectoparasites, citing paragraphs 0677 and 0686. However, this argument is unpersuasive for reasons provided in the body of the rejection above and because a review of paragraphs 0677 and 0686 shows that Schwarz suggests a combination of active ingredients, reciting groups INS-1 to INS-25. Paragraph 0686 recites cyclic depsipeptides, for example emodepside but nothing in these cited paragraphs suggest or teach away from combining elements of Schwarz with Ring et al.
Further, the applicants argue that the “Specification includes data demonstrating unexpected results sufficient to rebut the purported prima facie case of obviousness”, pointing to pages 40-42. However, this argument is unpersuasive because the results shown are not commensurate with the present claims which are generic to Aureobasidin A. A review of Tables 1-5 in pages 40-42 shows specific combinations of Aureobasidin A (component (A) with either of components (B): difenoconazole, mefentrifluconazole, imazalil or fenhexamid. Also, the Tables show unpredictability in the results. For example, Aureobasidin A alone showed 11% inhibition whereas 10X the amount showed no inhibition. Thus, the expected additive value % (determined by the Colby equation) compared to the observed value is confusing regarding the level of synergism. Also, the Ratios shown in the Tables are not commensurate with the scope of the ratios recited in the claims.
Conclusion
No claim is allowed.
Related prior art which may be applied in a future office action if appropriate:
Wuts et al (“Generation of Broad-Spectrum Antifungal…” ACS Medicinal Chemistry Letters, published April ed 23, 2025; IDS ref). Wuts et al discloses antifungal compounds derived from Aureobasidin A.
Nishimura et al (TW 1669060 published 08/21/2019).
Byler et al (2013; of record).
Gao et al (Feb 2020; of record).
Makarasen et al (2017; of record).
Yangmei et al (2010; of record).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658