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. Status of the Claims Claims 1-13 are pending and examined. Specification The use of the terms in paragraph 24, e.g., which include trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term . Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Claim Rejections - 35 USC § 112 Claim 13 is a “use” claim. According to M.P.E.P. § 2173.05(q) : Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). Claim Rejections - 35 USC § 101 Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite a “use” without an accompanying step for administering or applying the claimed product. Claim Rejections - 35 USC § 112 Claims 2, 3, 7 , and 9 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. The term “ preferably ” in the claims renders the claim indefinite as a preference is not required, although the claims are intended to set forth the required metes and bounds. This is also the use of a narrow numerical range that falls within a broader range, which can render a claim indefinite for the same reasons set forth above. See also M.P.E.P. § 2173.05(c) . 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. Claim s 11 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for preventing treating oomycete pathogens , does not reasonably provide enablement for prevention and treatment of all infestation by f ungal organisms . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. According to Dr. Gar y W. Moorman , “Fungal Root Rots and Chemical Fungicide Use,” July 8, 2025 , “ No single fungicide will kill or inhibit the growth of all fungi . In fact, some chemicals will allow certain fungi to cause more damage than usual because the chemical eliminates fungi that compete with the disease-causing fungus.” The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde , 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands , 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below Nature of the Invention : As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.” In the instant case, the claimed invention pertains to compounds of Formula (I), which are alleged by the Specification to treat and prevent all fungal infections. The State of the Prior Art and the Relative Skill of those in the Art : As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.” According to Dr. Gar y W. Moorman , “Fungal Root Rots and Chemical Fungicide Use,” July 8, 2025, “ No single fungicide will kill or inhibit the growth of all fungi . In fact, some chemicals will allow certain fungi to cause more damage than usual because the chemical eliminates fungi that compete with the disease-causing fungus.” As discussed above, the instantly claimed invention pertains to compounds of Formula (I), which are alleged by the Specification to act as gene delivery carrier compounds. At the time the instant application was filed, it would have been known by those of ordinary skill in the art that - due in large part to the strict requirement of complementarity between a compound and its corresponding binding site on a target receptor or enzyme - compounds, in the vast majority of cases, demonstrate a remarkably high correlation between their structure, specificity and ability to produce a pharmacological effect. At the same time, it would have also been generally assumed that two compounds with similar chemical properties would exhibit similar biological effects. Thus, given a series of compounds that are shown to exert an activity of interest (or given a target of interest), the ordinarily skilled artisan would have expected that a limited genus of related compounds (e.g., compounds exhibiting near equal molecular shapes and volumes, approximately the same distribution of electrons, and similar physical properties such as hydrophobicity, etc . ) would interact with the given target to elicit a related biological response. The Level of Predictability in the Art : Once a compound has been identified by ligand based and/or structure based drug design methods as potentially binding to the target molecule, it must be evaluated. Usually, several molecules which scored well during the docking run are evaluated in further tests since even the top scoring molec ule could fail in vitro assay. Finally, leads are brought into the wet lab for biochemical evaluation. A low level of predictability is not surprising considering that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. Indeed, modifying even a single atom in a compound can dramatically change the compound’s overall structure and - even though complementarity in one portion of the compound might be improved by the chemical revision - the overall binding or activity might be severely compromised. The Amount of Direction Provided by the Inventor / Existence of Working Examples : There are no working examples in the Specification of the composition preventing or treating any particular fungal infection. The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. The instant Specification provides examples of claimed compounds. No use of the claimed combination has been provided. The prior art recognizes a use for these components as shown in the cited prior art. See Cohen et al. , among others. While the stability data and synthesis data for the compounds is provided, this does not show that the claimed agents will have a claimed effect of preventing and controlling an infestation at any concentration. Claim 11 depends from claim 1, which does not require any particular concentration of any component other than 40% of a lactamide compound. A lactamide compound can be used as a solvent, not an active fungicide. Scope or Breadth of the Claims : As stated in MPEP 2164.01(c), “when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection for nonenablement based on how to use” (emphasis added). Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright , 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added). At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt , 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner , 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims". Amgen, In c . , v. Chugai Pharmaceutical Co., Ltd . (Fed. Cir. 1991). As noted by the court in In re Fisher , 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac , 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore , 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”. As to the first inquiry, as discussed above, the claims are drawn to compounds of Formula (I), which are alleged by the Specification to act as gene delivery compounds . Considering that Formula (I) encompasses tens of thousands of compound species, and potentially more , it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses approximately 16 compounds encompassed by Formula (I) as recited by the claims. As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below. Amount of Experimentation Necessary : In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to compositions , which are alleged by the Specification to act as fungicides . Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan (armed with screening techniques including computer assisted virtual screening techniques such as ligand-based and structure-based design methods) could not reasonably predict which of the tens of thousands of compounds encompassed by Formula (I) would exert the alleged activity bas ed on the limited disclosure of active compounds . Although the skilled artisan would have known that certain chemical modifications to the disclosed compounds may predictably provide structurally related compounds having similarly activity, the skilled artisan would have also known that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. According to Dr. Gary W. Moorman , “Fungal Root Rots and Chemical Fungicide Use,” July 8, 2025, “ No single fungicide will kill or inhibit the growth of all fungi . In fact, some chemicals will allow certain fungi to cause more damage than usual because the chemical eliminates fungi that compete with the disease-causing fungus.” The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde , 242 U.S. 261 (1916) which Thus, in order to identify those fungi that can be controlled and treated and to determine concentrations of the same for those fungi would require undue testing and experimentation . Given the unpredictability of the chemical arts , it is highly unpredictable whether the claimed composition at any concentration can inhibit all fungi . As such, the only way to ascertain which of the claimed compounds would do so would require undue experimentation. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure. 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. Claim s 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al. , “ Oxathiapiprolin-based fungicides provide enhanced control of tomato late blight induced by mefenoxam-insensitive Phytophthora infestans ,” PLOS One September 27, 2018 , in view of Mertoglu et al. , (US2017/0049097), in view of in view of Boyce et al. , (U.S. Pat. No. 4,138,402) , and in view of Street et al. , (US2011/0318272). Cohen teaches oxathiapiprolin (OXPT) is a new fungicide with high efficacy against plant pathogens. Mixtures were compared including one with OXPT and mefenoxam (MFX) in a weight ratio of 1:3. “Of the four mixtures, OXPT+MFX outperformed, with the highest preventive, curative, translaminar, and systemic efficacies. In the field, OXPT+MFX was superior to other fungicides in controlling late blight epidemics induced by MFX-insensitive isolates. ” Abstract. In field experiments a synergy factor was calculated suggesting a synergy between OXPT+MFX . See p16, 4 th full par. The examiner notes that a ratio of 1:3 OXPT to MFR is included in claim 4, which includes a ratio of 1:3 in the form of percentages of OXPT to MFX of 5:15 and 10:30, e.g. Cohen also teaches percentage of OXPT to MXF in a ready to use mixture of 7% and 21%, respectively. See Table 1, p3. This falls within the claimed ranges. Cohen does not teach the claimed lactamide. Mertolgu teaches a composition for controlling phytopathogenic fungi and undesired vegetation, mites, insects by applying the concentra te or emulsion to pests, their environment, crops, soil, plants, etc. See par. 1. The lactamide can include one with a claimed formula (I). See par. 4. A lactamide includes N,N-dimethyl lactamide . See par. 197. The lactamide can be used in a concentration of up to 4 5%. See par. 21 . Pesticides that can be used include fungicides and at least one can be used. The fatty acid amide hydrolase inhibitors that can be used is oxathiapiprolin . See par. 45. The nucleic acid synthesis inhibitors the can be used include metalalyx-M. See par. 33. Emulsifiers and dispersants can be used as excipients. See par.’s 172 and 173. Mertoglu does not teach identical concentrations of emulsifier and dispersing agent. Boyce teaches a fungicide composition comprising 3-10% dispersing agent up to 50% solvent, and 2- 20% emulsifiers. See Abstract. Similarly, Street teaches a pesticidal composition comprising 1-20% emulsifier. See par. 47. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to combine the teachings of Cohen, Mertoglu, Boyce, and Street to arrive at the claimed method. One would do so because Cohen teaches the claimed combination to be synergistically advantageous as a ready to use fungicide mixture at claimed concentrations. Mertoglu teaches using the claimed lactamide in fungicide compositions with claimed excipients for application to the claimed targets and include the claimed fungicide components as usable therein. Finally, while optimizable parameters, Boyce and Street more particularly set out the use of fungicides with the claimed concentrations of emulsifiers and dispersing agents. As such, there is a reasonable and predictable expectation of success in arriving at the claimed compositions at the claimed concentrations and ratios for the claimed uses. As such, no claim is allowed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JARED D BARSKY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2795 . The examiner can normally be reached on FILLIN "Work schedule?" \* MERGEFORMAT 9-5 M-F . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272- 1310 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JARED BARSKY/ Primary Examiner, Art Unit 1628