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 6 April, 2022, is a national stage application of PCT/EP2020/078248, filed 8 October, 2020, which claims foreign benefit of Application N° EP20177852.9, filed 2 June, 2020; EP19215749.3, filed 12 December, 2019; and EP19202293.7, filed 9 October, 2019.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 20 February, 2026, in the matter of Application N° 17/767,018. Said documents have been entered on the record.
Claims 10 and 12 are amended. Claims 13-14, 17-20 and 22 are canceled. No new matter was introduced.
Claims 11, 15-16, and 21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Thus, Claims 1-10 and 12 represent all claims currently under consideration.
Response to Amendments/Arguments
Claims 13-14, 17-20 and 22 have been canceled. Therefore, the rejections of these claims under 35 U.S.C. 112(b), 112(d), 103 and Non-Statutory Double Patenting are moot.
Applicant’s amendments are sufficient to overcome the rejections of Claims 10 and 12 under 35 U.S.C. 112(b).
The remaining rejections under 35 U.S.C. 112(b) of Claims 1-3, and therefore Claims 4-9 which depend from Claim 1, refer to the indefiniteness of the blurry images within the claims that depict Structures S1-S39 with unclear connections and dangling bonds. Applicant argues that the structures “appear clearly in the document as filed” (Remarks, Pg. 65), which is unpersuasive. The structures as reproduced in the claims are of insufficient clarity such that the scope of the claimed subject matter cannot be determined with reasonable certainty. The fact that a clearer version of the structure may appear elsewhere in the specification does not remedy the lack of clarity in the claims themselves, as the claims must be clear on their face. See MPEP 2173.05(s). Accordingly, the rejections are maintained.
Regarding the rejections under 35 U.S.C. 103 for Claims 1-7, 9-10 and 12, Applicant argues that Grimm’s hydride displacement law, as taught by Patani, is directed to medicinal chemistry and pharmacokinetic considerations and is therefore not applicable to the presently claimed pesticidal compounds (Remarks, Pg. 67-68). This argument is not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Tosatti discloses compounds that significantly overlap in structure with the presently claimed compounds and are used for the same pesticidal purpose, and therefore constitutes analogous art and an appropriate starting point for modification. Patani teaches general principles of bioisosteric substitution, which relate to the structural and electronic properties of chemical substituents and are applicable to organic compounds broadly, irrespective of the intended end use. The fact that Patani discusses such substitutions in a medicinal chemistry context does not limit the applicability of the underlying chemical principles to other fields, including agrochemical or pesticidal compositions. See §MPEP 2141.01(a) (a reference is relevant for all that it teaches to one of ordinary skill in the art) and See MPEP §2123(II) (Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971)).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning (Remarks, Pg. 68), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant further argues that substitution of hydrogen with an amino (-NH2) group would not be considered equivalent and would introduce steric differences, allegedly discouraging such modification (Remarks, Pg. 68-69.) However, obviousness does not require substituents to be equivalent, but rather that there is a reason to make the substitution with a reasonable expectation of success. See MPEP §2143 (requiring articulated reasoning with rational underpinning). Patani explicitly teaches that substitution of hydrogen with -NH2 represents a recognized bioisosteric modification under Grimm’s hydride displacement law, which is routinely employed to modulate the electronic and physicochemical properties of compounds. The known difference in steric and electronic properties between hydrogen and -NH2 would have provided motivation to explore such substitutions as part of routine structural variation, rather than teaching away from them. See MPEP §2143.02 (reasonable expectation of success does not require absolute predictability). Accordingly, the arguments are unpersuasive, and the rejections are maintained.
Regarding the rejections under Non-Statutory Double Patenting, Applicant states that a terminal disclaimer may be filed upon indication of allowable subject matter (Remarks, Pg. 69). This statement is not persuasive and does not overcome the non-statutory double patenting rejection. The filing of a terminal disclaimer is required to obviate a nonstatutory double patenting rejection, and a mere indication that Applicant “will consider” filing such a disclaimer at a later time does not place the application in condition for allowance. See MPEP §804.02. Accordingly, the rejections are maintained.
Claim Rejections - 35 USC § 112 (MAINTAINED)
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 1-9 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.
Claims 1-3 contain structures designated S1-S39 which have unclear connections and dangling bonds. See for example,
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. Correction is required.
Claims 4-9 are dependent from Claim 1, and fail to cure the deficiencies as stated above.
Claim Rejections - 35 USC § 103 (MAINTAINED)
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 1-7, 9-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tosatti and Wach. (WO 2017/192385 A1, cited in IDS), hereinafter Tosatti, further in view of Patani and LaVoie (Chemical Reviews, 1996, Vol. 96, No. 8), hereinafter Patani.
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‘385 shares an Applicant with the instant Application.
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Regarding Claims 1-7 and 9-10, Tosatti teaches heteroaryl-triazole compounds of formula I (‘385, Pg. 2, Lines 7-8), shown top right, for controlling ectoparasites. One embodiment is exemplified in Compound 52 (‘385, Pg. 40, Table 2, CAS RN 2149617-81-0), shown bottom right, which significantly overlaps the instant Formula I, wherein X is O (as in instant claims 1-6), Y is a bond (as in instant claims 1-6 and 10), R1 is H (as in instant claims 1-6), R2 is phenyl substituted with -CN (as in instant claims 1-4, 6-7), R3a is H (as in instant claims 1-6 and 10), R3b is methyl (as in instant claims 1-6 and 10), R4 is pyrimidine (as in instant claims 1-6 and 10), and R5 as an H.
Tosatti’s Compound 52 fails to disclose R5 as -NH2 (as in instant claims 1-6 and 10), instead of H, nor that R21 could be -NH2, instead of H (as in instant Claim 9.)
However, Patani discloses a direct adaptation of Grimm’s Hydride Displacement Law which teaches a monovalent group of isosteres, namely fluorine, hydroxyl, amino, or methyl groups as replacements for hydrogen (1996, Pg. 3152, §4, and Table 9), which share similar physicochemical properties.
Regarding Claim 12, Tosatti teaches formulation comprising a compound of the invention, or a salt thereof, and at least one acceptable carrier (‘385, Pg. 4, Lines 10-11.) As disclosed by Applicant, “the carrier may also be a liquefied gaseous extender” (instant Specification, Pg. 117, Line 16.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify Tosatti’s compound 52 by substituting the hydrogen at the R5 position with as amino group, as taught by Patani, in accordance with Grimm’s Hydride Displacement Law. One would have been motivated to make this substitution as a conventional and predictable bioisosteric replacement, recognizing that hydrogen and amino groups are closely related bioisosteres with similar physicochemical behavior. Such a modification would have been routinely employed to adjust polarity, hydrogen-bonding potential, or metabolic stability, while maintaining pesticidal activity. One would have had a reasonable expectation of success because Patani explicitly teaches that interchanging hydrogen, fluorine, hydroxyl, amino, or methylene groups constitutes a routine substitution yielding compounds with comparable physicochemical and biological properties. Accordingly, substituting and amino group for hydrogen would have been expected to produce a compound exhibiting substantially similar pesticidal effectiveness against ectoparasites.
Double Patenting (MAINTAINED)
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 1-10 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 5-10, 13-16, and 18-19 of U.S. Patent No. 11,528,907 and Claim 1 of U.S. Patent No. 11,864,557.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to compounds, compositions, and formulations that differ only in obvious variations of substituents, which do not result in a patentably distinct invention. The claimed subject matter and the prior patents both encompass substantially the same core structures and are intended for the same use in controlling or treating the same type of animal or ectoparasitic pests.
Claims 1-10 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4, 7-8, and 10-11 of U.S. Patent No. 12,116,357 and Claims 1-6, and 10 of U.S. Patent No. 12,187,705 in view of Patani (Chemical Reviews, 1996, Vol. 96, No. 8, cited above.)
Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds and compositions of the instant application and those of the earlier patents share the same core structural framework and differ only by substitution at the R5 position, wherein the prior patents recite hydrogen, methyl, or trifluoromethyl, while the instant application employs structurally and electronically analogous substituents.
However, Patani discloses a direct adaptation of Grimm’s Hydride Displacement Law which teaches a monovalent group of isosteres, namely fluorine, hydroxyl, amino, or methyl groups as replacements for hydrogen (1996, Pg. 3152, §4, and Table 9), which share similar physicochemical properties.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the compounds of the previous patents by substituting the hydrogen at the R5 position with as amino group, as taught by Patani, in accordance with Grimm’s Hydride Displacement Law. One would have been motivated to make this substitution as a conventional and predictable bioisosteric replacement, recognizing that hydrogen and amino groups are closely related bioisosteres with similar physicochemical behavior. Such a modification would have been routinely employed to adjust polarity, hydrogen-bonding potential, or metabolic stability, while maintaining pesticidal activity. One would have had a reasonable expectation of success because Patani explicitly teaches that interchanging hydrogen, fluorine, hydroxyl, amino, or methylene groups constitutes a routine substitution yielding compounds with comparable physicochemical and biological properties. Accordingly, substituting and amino group for hydrogen would have been expected to produce a compound exhibiting substantially similar pesticidal effectiveness against ectoparasites.
Claims 1-10 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-2, 7-9, 12-15, and 18-20 of copending Application No. 17/628,519, Claims 1-8 and 16 of copending Application No. 17/628,542, Claims 1-9 and 17 of copending Application No. 17/762,779, Claims 1-11, 14-15, and 20-24 of copending Application No. 17/997,884, and Claims 1-9 and 18-20 of copending Application No. 18/818,025.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to compounds, compositions, and formulations that differ only in obvious variations of substituents, which do not result in a patentably distinct invention. The claimed subject matter and the copending applications both encompass substantially the same core structures and are intended for the same use in controlling or treating the same type of animal or ectoparasitic pests.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
Prosecution Insights