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 .
DETAILED ACTION
Status of 18/546,518
Claims 1-18 are currently pending.
Priority
Instant application 18/546,518, filed 8/15/2023, claims priority as follows:
PNG
media_image1.png
86
389
media_image1.png
Greyscale
Receipt of the foreign priority application is acknowledged.
Information Disclosure Statement
All references from the IDS submitted on 8/15/2023 have been considered unless marked with a strikethrough.
Election/Restriction
Applicant’s election of Group I, claims 1-14, drawn to an agrochemical fungicidal composition comprising at least one conazole fungicide and an anionic surfactant, with traverse in the reply filed 3/16/2026, is acknowledged. Applicant’s election of prothioconazole as the conazole fungicide and ethoxylated sodium isotridecyl ether sulfate having 20 ethylene oxide units as the anionic surfactant, in the same reply is also acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and prior art was identified. See the 103 rejection below. During the search, an additional expanded species was identified where the anionic surfactant is a polyarylphenyl ether phosphate. See the 102 rejection below. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1-4, 6-8, and 10-14 read on the elected and expanded species. Claims 5, 9, and 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
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 1-4, 6-8, and 10-14 are 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 claims 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims of the instant application embrace an agrochemical fungicidal composition comprising at least one conazole fungicide or a salt, an ester, or an isomer thereof, and an anionic surfactant. Particularly, the terms “ester” and “isomer” recited in claims 1 and 3-4 invoke the 35 U.S.C. 112(a) rejection, and claims 2, 6-8, and 10-14 depend from the above claims. Even a cursory calculation of the number of compounds embraced in the instant claims would result in thousands of compounds.
Level of skill and knowledge in the art
The level of skill and knowledge in the art is high.
Partial Structure
Agrochemical fungicidal compositions have been disclosed and example composition species that would be within the general scope have been disclosed. However, as to the claimed isomers and esters, no specific examples are given that would demonstrate possession or put the public in possession of all the claimed isomers and esters of the agrochemical fungicidal compositions.
It is generally accepted that isomers have identical chemical formulae but differ in properties and the arrangement of atoms in the molecule. Additionally, esters, may vary by chemical formulae and may also differ in properties and the arrangement of atoms in the molecule.
Physical and/or chemical properties/functional characteristics
The agrochemical fungicidal compositions and isomers and esters thereof, are compounds which are allegedly useful in treatment of fungal diseases in plants by inhibiting or killing the fungi causing the diseases. Although the art recognizes generally accepted definitions, the terms are not explicitly defined by the specification in such a way as to demonstrate that the inventor had possession of the isomers and esters of the agrochemical fungicidal combinations.
A review of the prior art identifies the reference Kishimoto (Kishimoto, T. et. al. Int. J. Mol. Sci. 2020, 21(1), 34) that discloses a classic case of isomerism. Cisplatin, an active isomer, is active in cancer treatment whereas transplatin, the inactive isomer, is inactive in cancer treatment (Introduction, last sentence). In view of the teachings of Kishimoto, it is unknown which of the isomers of conazole fungicides claimed by Applicant is will be active or inactive. Further, one of ordinary skill in the art would not be able to predict which compounds, of the vast number that are claimed, will be active or inactive absent evidence.
Additionally, the reference Najjar (Najjar, A. & Karaman, R. Expert Opinion on Drug Discovery, 2018, 14(3), 199-220) discloses successes and failures of prodrugs of known pharmaceuticals, and specifically teaches an example of an ester (abstract and page 212, section 3). Najjar teaches hetacillin, an ester prodrug of ampicillin, which was withdrawn since it did not have a superior advantage when compared to ampicillin. In light of Najjar, it is unknown which of the esters of the conazole fungicides claimed by Applicant is will be active or inactive. Further, one of ordinary skill in the art would not be able to predict which compounds, of the vast number that are claimed, will be active or inactive absent evidence. There is no structure/function correlation in the specification showing which esters would or would not be active.
Since Applicant has not set forth compounds or substituents of the conazoles of the agrochemical fungicidal compositions in the specification which Applicant considers isomers or esters, it is not clear what compounds fall under the isomers or esters of conazoles. Applicant has not described which isomers or esters of conazoles in the agrochemical fungicidal composition have the ability to control fungal diseases in plants, and which do not. Stated differently, there is no structure/function correlation and no representative number of specific examples of isomers or esters that demonstrate which compounds retain activity. Further, one of ordinary skill in the art would not be able to predict the biological activity of the claimed isomers or esters of the conazole of the agrochemical fungicidal compositions.
Predictability of the art
Medicinal chemistry is an experimental science with a low predictability level. Small changes in the structure of a compound can lead to large differences in their pharmacological activity. Regarding isomers or esters, predicting if a certain claimed compound retains the activity and function of the original drug is filled with experimental uncertainty because isomers and esters contain variation by chemical and physical properties of the molecules.
Method of making the claimed invention
Although the specification provides a method for making the agrochemical fungicidal compositions, no method for making all of the compositions, including the isomers or esters of the conazole, encompassed by the instant claims has been disclosed. Methods of synthesizing compounds are, in general, known to a person of ordinary skill; however, methods of making the myriad of compounds encompassed by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as isomers and esters of the conazole ingredient are merely described partially.
As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the isomers or esters because the examples illustrated in the experimental section are limited to only conazoles of the agrochemical fungicidal compositions.
Substantial and undue experimentation would be needed to practice Applicant’s invention because the specification lacks sufficient detail to show how to use the isomers or esters of the instant invention. Further, there is no guarantee that all of the isomers or esters embraced by the scope of the claims would be use in controlling fungal diseases in plants.
Even with the undue burden of experimentation, there is no guarantee that one would obtain the product of a desired isomers or esters. Although some functional characteristics are disclosed or would be known to a person of ordinary skill in the art, in the absence of a disclosed structure, there can be no correlation between the function and structure of the claimed isomers or esters in the instant application.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claim(s) are broad and generic with respect to all possible compounds encompassed by the claims: the possible structural variations are limitless to any isomers or esters of the conazole of the agrochemical fungicidal compositions. In the instant case, however, the specification does not disclose a sufficient variety of species to reflect this variance in the genus. Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims such as isomers and esters of conazoles.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Dependent claims 2, 6-8, and 10-14 do not resolve the 112(a) written description rejections raised in claims 1, 3, and 4, since those claims do not further limit or provide further structure of the isomers or esters of the conazoles. Accordingly, these claims are also rejected. This rejection would be overcome by amending the claims to remove the terms, “isomer” and “ester”.
Claim Rejections - 35 USC § 103 – Elected Species
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 1-4, 6, 8, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sipcam Oxon S.P.A. (WO 2021/024189 A1, cited in the IDS Of 8/15/2023, herein after “Sipcam”), and further in view of BASF (https://global-uploads.webflow.com/60d08519487ac8863ef9cf41/620990b50b70dca84f61fd00_Disponil%C2%AE%20BES%2020_TDS.pdf, published March 2017, accessed May 14th 2026). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The reference Sipcam discloses aqueous compositions comprising prothioconazole, the production process thereof, and the use of the composition in treatment of fungal infections in plants (abstract). Specifically, Sipcam teaches compositions 9 and 10 in Table 1B (page 13), which consists of the conazole fungicide prothioconazole and Soprophor® 4D384, which is tristyrylphenol ethoxylate sulfate ester, an anionic surfactant.
With respect to claim 2, Sipcam teaches the compositions are aqueous suspension concentrates (page 13, line 21), which indicates a liquid composition.
With respect to claim 11, the compositions of Sipcam contain a 35.1% w/w of prothioconazole (page 13, Table 1B).
With respect to claim 12, the compositions of Sipcam contain a 1% w/w of the anionic surfactant Soprophor® 4D384 (page 14, Table 1B).
With respect to claim 13, Sipcam teaches the ratio of prothioconazole to Soprophor® 4D384 as 35.1:1 (page 14, Table 1B).
With respect to claim 14, Sipcam teaches the additional fungicide chlorothalonil in fungicidal compositions with prothioconazole (page 12, Table 1A).
The reference BASF teaches the anionic surfactant Disponil® BES 20, which is ethoxylated sodium isotridecyl ether sulfate having 20 ethylene oxide units (pages 2 and 3). BASF also teaches that Disponil® BES 20 is used as an alternative for alkylphenol ethersulfates (page 1), of which Soprophor® 4D384 is.
Ascertaining the differences between the prior art and the claims at issue
The reference Sipcam fails to teach ethoxylated sodium isotridecyl ether sulfate having 20 ethylene oxide units as the anionic surfactant.
The reference BASF fails to teach prothioconazole.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of fungicidal combinations. An artisan possess the technical knowledge necessary to make adjustments to the fungicidal combinations to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said fungicidal combinations and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
Applying KSR prong (B), it would have been prima facie obvious for one of ordinary skill in the art to substitute the anionic surfactant Soprophor® 4D384 of Sipcam with the ethoxylated sodium isotridecyl ether sulfate having 20 ethylene oxide units, also known as Disponil® BES 20, of BASF, because they are both anionic surfactants, and BASF teaches that the ethoxylated sodium isotridecyl ether sulfate having 20 ethylene oxide units is an alternative for alkylphenol ethersulfates, of which Soprophor® 4D384 is. One or ordinary skill in the art would be motivated before the effective filing date to make this substitution because they are both known in the art to perform the same function, and thus are expected to have similar results. A skilled artisan would have readily predicted that substituting Soprophor® 4D384 with the ethoxylated sodium isotridecyl ether sulfate having 20 ethylene oxide units would be successful in light of the teachings of Sipcam and BASF.
With respect to claims 11, 12, and 13, it would have been prima facie obvious to one having ordinary skill in the art to arrive at the concentrations of prothioconazole and anionic surfactant recited in the instant claims because it is considered well within the capabilities of one of ordinary skill in the art to optimize the concentrations of individual ingredients of the formulation to provide optimal fungicidal compositions. The concentration of each individual ingredient in the formulation is a result effective parameter that will affect the physical properties of the final composition. The amount of prothioconazole in a composition is clearly a result effective parameter that a person of ordinary skill would routinely optimize, as is the anionic surfactant. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, the concentrations and ratios of prothioconazole and anionic surfactant disclosed by Sipcam and BASF above, provide a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal ratio of prothioconazole and anionic surfactant to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. See MPEP § 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Claim Rejections - 35 USC § 102 – Expanded Species
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-7, and 11-14 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sipcam Oxon S.P.A. (WO 2021/024189 A1, cited in the IDS Of 8/15/2023, herein after “Sipcam”). This rejection applies to the expanded species.
The reference Sipcam teaches as disclosed above, and at least those teachings are incorporated herein. Furthermore, the Examiner notes the anionic surfactant Soprophor® 4D384 qualifies as an alkyl ether sulfate, with respect to claim 6, and a polyarylphenol polyalkoxyether sulfate, regarding claim 7. Thus, Sipcam also anticipates instant claims 1-4, 6-7, and 11-14.
Conclusion
Claims 1-4, 6-8, and 10-14 are rejected. Claims 5, 9, and 15-18 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights