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 .
Priority
This application, filed 19 October, 2022, is a national stage application of PCT/EP2021/060082, filed 19 April, 2021, which claims foreign benefit of application EP20170542.3, filed 21 April, 2020.
Information Disclosure Statement
Two information disclosure statements (IDS) submitted on 19 October, 2022 and 25 April, 2025 are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 19 October, 2022, in the matter of Application N° 17/996,550. Said documents have been entered on the record.
Claims 1-11 have been amended. No new matter was introduced.
Thus, Claims 1-11 represent all claims currently under consideration.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1-3 and 5-6 are objected to because of the following informalities: clarity of option “V”. The claim language defining Markush group V contains multiple alternative clauses separated by “or,” which may obscure the intended grouping of alternatives. Applicant is requested to clarify the structure of the alternatives, for example by separating the alternatives into subparagraphs or otherwise improving punctuation.
Appropriate correction is required.
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.
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 10-11 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.
Claim 10 recites the phrase “comprising allowing a compound of formula (I) according to Claim 1 or an agrochemical formulation thereof is allowed to act…” which contains inconsistent verb structure and therefore renders the scope of the method unclear.
Applicant might amend the claim to read “A method for controlling one or more animal pests, comprising allowing a compound of formula (I) according to Claim 1 or an agrochemical formulation thereof to act on the animal pests and/or a habitat thereof.”
Or alternatively, “A method for controlling one or more animal pests, comprising applying a compound of formula (I) according to Claim 1 or an agrochemical formulation thereof to the animal pests and/or a habitat thereof.”
Claim 11 recites the phrase “for controlling one or more animal pests” appears to recite an intended use rather than a structure limitation of the claimed product.
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.
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 1-11 rejected under 35 U.S.C. 103 as being unpatentable over Mosrin et al. (US 10,772,332 B2, linked to WO 2018/141954 A1, both cited in IDS), hereinafter Mosrin, and further in view of Meanwell (Top Med Chem. 2015. 9: 283–382.)
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Reference shares same Applicant and multiple inventors with instant application.
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Regarding Claims 1-7 and 11, Mosrin teaches 2-(het)aryl-substituted fused heterocycle derivatives of the formula (I), to the use thereof as acaricides and/or insecticides for controlling animal pests to include Compound I-001 (‘332, Col 105, Table 3, Example I-001), shown top right, which significantly overlaps the instant Formula I, shown middle right, wherein A1 is N, A2 is =CR4b, wherein R4b is methyl, A3 is N, Y is O, R1 is ethyl, R2 is H, R3 is H, R5 is CF3, R6 is H, n is 2, and V is a phenyl group substituted with Cl.
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While Mosrin fails to exemplify that the instant X can be other than N, Mosrin does suggest additional options in its genus of Formula I (‘332, Col 2, Lines5-17), shown bottom right, wherein A2 (equivalent to the instant X) is N(R6), O, or S.
This differs from the instant X which allows for O or S only.
However, Meanwell teaches the immense utility of heterocycles resides in their typically facile synthetic accessibility combined with the versatility to project a range of vectors while the electronic properties of the ring can readily be modulated by the introduction of additional heteroatoms and substituent selection (2015, Pg. 291, §2.3 and Pg. 295, Fig. 4 and Table 3.)
Regarding Claims 8-9, Mosrin teaches formulations and use forms prepared therefrom as pesticides (‘322, Col 53, Lines 2-3), the formulations, in addition to one or more compounds of the formula (I), optionally comprise further active agrochemical ingredients (‘322, Col 53, Lines 30-32.)
Regarding Claim 10, Mosrin teaches methods for controlling animal pests, in which compounds of the formula (I) are allowed to act on animal pests and/or their habitat (‘322, Col 45, Lines 39-41.)
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to modify Mosrin’s compound by selecting oxygen or sulfur for the heteroatom at position A2/X. The selection of oxygen or sulfur from the small, finite set of heteroatom options explicitly taught by Mosrin would have constituted no more than routine optimization of a known compound scaffold using well-established medicinal chemistry principles, as taught by Meanwell, and would have been expected to yield predictable variants of the same therapeutically active compounds with a reasonable expectation of success.
Double Patenting
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2, 4 and 8-13 of U.S. Patent No. 10,745,398.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims disclose compounds having the same core scaffold and therapeutic use as the presently claimed compounds. Selection of specific substituent options disclosed in the patented claims result in compounds that fall within the scope of the presently claimed genus (e.g., R2 is Q-51, V is V-95, and X is H-4, etc.) Accordingly, the presently claimed compounds represent no more than obvious variations of the patented compounds because they arise from routine selection of substituents expressly taught in the patented genus for the same purpose.
Additionally, Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 3 and 5-7 of the same U.S. Patent No. 10,745,398 in view of Meanwell (Top Med Chem. 2015. 9: 283–382.)
To the extent that the presently claimed compounds differ from the patented compounds in the identity of a heteroatom at instant position X within the bicyclic ring, the substitution of heteroatoms such as N, O or S at a given position in a heterocycle is a recognized form of bioisosteric modification routinely employed in medicinal chemistry to generate closely related analogs with similar biological activity (Meanwell, 2015, Pg. 291, §2.3 and Pg. 295, Fig. 4 and Table 3.) Because the patented claims already teach the scaffold and therapeutic use of the compounds and identify the heteroatom position as a site of permissible variation, it would have been obvious to substitute one heteroatom for another such as replacing nitrogen with oxygen or sulfur to obtain the presently claimed compounds.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2 of U.S. Patent No. 10,772,332.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims disclose compounds having the same core scaffold and therapeutic use as the presently claimed compounds. Selection of specific substituent options disclosed in the patented claims result in compounds that fall within the scope of the presently claimed genus (e.g., A2 is O or S, R2 is Q-52, etc. in the patented positions) Accordingly, the presently claimed compounds represent no more than obvious variations of the patented compounds because they arise from routine selection of substituents expressly taught in the patented genus for the same purpose.
Additionally, Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 3-10 of the same U.S. Patent No. 10,772,332 in view of Meanwell (Top Med Chem. 2015. 9: 283–382.)
To the extent that the presently claimed compounds differ from the patented compounds in the identity of a heteroatom at position A2, the substitution of heteroatoms such as N, O or S at a given position in a heterocycle is a recognized form of bioisosteric modification routinely employed in medicinal chemistry to generate closely related analogs with similar biological activity (Meanwell, 2015, Pg. 291, §2.3 and Pg. 295, Fig. 4 and Table 3.) Because the patented claims already teach the scaffold and therapeutic use of the compounds and identify the heteroatom position as a site of permissible variation, it would have been obvious to substitute one heteroatom for another such as replacing nitrogen with oxygen or sulfur to obtain the presently claimed compounds.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-13 of copending Application No. 18/559,710 in view of Meanwell (Top Med Chem. 2015. 9: 283–382.)
The copending and instant claims disclose compounds having the same core scaffold and therapeutic use as the presently claimed compounds differing primarily in the identity of a heteroatom at position ‘710’s A2 (equivalent to the instant position X), the substitution of heteroatoms such as N, O or S at a given position in a heterocycle is a recognized form of bioisosteric modification routinely employed in medicinal chemistry to generate closely related analogs with similar biological activity (Meanwell, 2015, Pg. 291, §2.3 and Pg. 295, Fig. 4 and Table 3.) Because the copending claims already teach the scaffold and therapeutic use of the compounds, it would have been obvious to substitute one heteroatom for another as taught by Meanwell, to obtain the presently claimed compounds.
This is a provisional nonstatutory double patenting rejection.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627