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 .
Priority
This application is a 371 of PCT/EP2022/064094 (05/24/2022)
And claims foreign priority to INDIA 202111024417 (06/01/2021)
And EP 21202529.0 (10/13/2021)
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-12, in the reply filed on 4/28/26 is acknowledged. The traversal is on the ground(s) that a lack of unity was not established. This is not found persuasive because as established in the Requirement for Restriction and additionally, the technical feature linking the claims of formula (I) is not a contribution over the art as evidenced by PubChem CID 121198339.
The requirement is still deemed proper and is therefore made FINAL.
Applicant also elected the following species:
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.
The full scope of the method claim was searched including the elected species. Thus, the restriction to the elected species is withdrawn.
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.
Claims 1-12 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the full scope of the claimed invention.
Claim 1 is to a “method of controlling or preventing infestation of useful plants by phytopathogenic microorganisms, comprising applying to the plants … a fungicidally effective amount of a compound, or a composition comprising the compound of formula (I):
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with variables defining a vast genus of alternatives including A1,A2,A3,B1,B2, R1-11, Z1. The specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation in view of the factors set forth in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), as follows. See also MPEP § 2164.01(a) and § 2164.04.
The breadth of the claims – the claims are to a method of using a “fungicidally effective amount” by administering a large genus of compounds whose species number in excess of billions of compounds.
The nature of the invention – the nature of the claimed invention is compounds acting as a fungicide.
The state of the prior art – the state of the art requires synthesizing and testing each compound to determine whether the compound is actually effective as a fungicide as demonstrated by Gómez et al. (Bioorg. Med. Chem. 16 (2008) 7908–7920) in a series of structurally related compounds.
The level of one of ordinary skill – the level of skill in the art is high as evidenced by Gómez et al. (Bioorg. Med. Chem. 16 (2008) 7908–7920).
The level of predictability in the art – the art is highly unpredictable due to the complex and generally unknown nature of the mode of action of the compounds. The particular art is also unpredictable because there is no known or articulated rationale for how the compounds are alleged to be effective. Furthermore, as evidenced by Gómez et al. (Bioorg. Med. Chem. 16 (2008) 7908–7920) in Table 2, structurally closely related compounds vary vastly in the level of activity with many considered inactive.
The amount of direction provided by the inventor – the primary guidance provided by the inventor is given in the Examples evaluating a select few compounds and administering compounds them to various plants. The compounds tested are primarily of the scope:
B1/B2 as CR10/R11; R8-R11 as H or CH3; Z1 as alkyl, cycloalkyl, phenyl, or 5-6-heteroaryl selected from pyrrole, pyrazole, thiazole, furan, or pyridyl; R1 as H, alkyl; R2: H, halo, alkyl, alkylcarbonimidoyl; R7 as H, alkyl, alkylcarbonyl, alkoxycarbonyl, alkylcarbonimidoyl, phenyl. There is no apparent correlation between the structure of the compounds within the claims and the level of activity achieved beyond generic cutoffs. This lack of supporting data and explanation would require one of skill in the art to question whether the examples support enablement of the full scope of the claims. Regarding effective amounts, the guidance provided regarding effective amounts is generic without any specificity related to response curves or other experimental data of compounds within the claims.
The existence of working examples – the examples in the specification are limited to a small subset of the full scope of the claimed compounds as applied to a narrow scope of plants.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure – given the high level of unpredictability in the art, the lack of a breadth of working examples, and the limited guidance provided with respect to activity of the examples, there would be a tremendous amount of experimentation required before one of skill in the art could use the compounds as claimed.
In view of the specification and evidence of record, one of skill in the art would be required to perform an undue amount of experimentation to test each of the compounds of the claims using an appropriate model and select candidates for further development in vivo, perform testing to determine effective amounts, and finally perform efficacy testing. Thus, one of skill in the art would be required to start ab initio and develop any compound within the scope of the claims. Such a level of experimentation is undue. Weighing the above factors by a preponderance of the evidence results in the conclusion that the claims are not enabled for for the full scope of Formula (I).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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