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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13 July, 2026 has been entered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 13 July, 2026, in the matter of Application N° 17/767,018. Said documents have been entered on the record.
Claims 1-4 are amended. 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Claims 11, 15-16, and 21 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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
Applicant’s amendments to enlarge the structure images are sufficient to overcome the rejections of Claims 1-9 under 35 U.S.C. 112(b).
Regarding the remaining rejections 35 U.S.C. 103 and Double Patent, Applicant's arguments filed 13 July, 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 35 U.S.C. 103 for Claims 1-7, 9-10 and 12, Applicant argues that Tosatti teaches away from substitution of the hydrogen atom at the R5 position with an amino (-NH2) group because Tosatti defines R5 as a finite list of substituents that does not include amino groups (Remarks, Pg 66). Applicant further argues that Patani limits the applicability of Grimm’s Hydride Displacement Law to “particular series of agents” in medicinal chemistry and therefore does not provide motivation to modify Tosatti’s pesticidal compounds (Remarks, Pg 66-67).
Applicant’s first argument improperly equates the absence of a disclosed substituent with a teaching away. Tosatti merely defines the substituents investigated within its disclosed genus and does not criticize, discredit, or otherwise discourage the use of amino substitution at the R5 position. A reference does not teach away merely because it discloses a finite or preferred set of embodiments while remaining silent regarding other possible structural modifications. Accordingly, the omission of an amino substituent from Tosatti’s disclosed R5 substituents is not evidence that one of ordinary skill in the art would have been discouraged from considering such a modification when additional teachings in the prior art provide a reason to do so.
Applicant also mischaracterizes the teachings of Patani. Patani is not relied upon for the proposition that hydrogen-to-amino substitution universally preserves biological activity or is applicable irrespective of the surrounding chemical environment. Rather, Patani is relied upon for its disclosure that substitution of hydrogen with fluorine, hydroxyl, amino, or methyl groups under Grimm’s Hydride Displacement Law represents a recognized bioisosteric strategy for modifying the physicochemical and electronic properties of organic compounds. The discussion in Patani regarding a “particular series of agents” concerns whether biological activity is retained within the specific compound series under investigation, not whether hydrogen-to-amino substitution itself constitutes a recognized structural modification available to one of ordinary skill in the art.
Indeed, Patani expressly evaluates hydrogen, fluorine, hydroxyl, and amino substitutions within particular chemical series in order to determine the effect of those recognized bioisosteric modifications on biological activity. Thus, rather than limiting the availability of the substitution itself, Patani demonstrates that such substitutions were routinely investigated by skill artisans as part of ordinary structure-activity relationship studies. Tosatti provides the structurally analogous pesticidal scaffold, while Patani provides a recognized chemical design principle for modifying substituents to alter physicochemical properties. The references are therefore relied upon for different, complementary teachings.
Applicant further argues that replacement of hydrogen with an amino group would introduce substantial steric, electronic, hydrogen-bonding, and acid-base differences that would discourage the proposed modification (Remarks, Pg 67). However, these differences do not weigh against obviousness. To the contrary, the known difference in physicochemical properties between hydrogen and amino substituents are precisely why bioisosteric substitutions are routinely explored during chemical optimization. Obviousness does not require that the substituted groups be identical or function equivalently in every respect; rather, it requires an articulated reason to make the modification with a reasonable expectation that the modification could be successfully investigated. See MPEP §2143. Patani provides such a reason by identifying hydrogen-to-amino substitution as a recognized bioisosteric modification used to alter molecular properties. Whether the resulting compound ultimately exhibits greater, lesser, or equivalent pesticidal activity is a matter of routine experimentation and does not negate the motivation to investigate the modification.
Applicant’s assertion that the rejection is based upon impermissible hindsight (Remarks, Pg 68) is likewise unpersuasive. The rationale supporting the rejection does not originate from Applicant’s disclosure, but from the combined teachings of Tosatti and Patani. Tosatti provides the structurally similar pesticidal compounds, while Patani provides the recognized chemical modification. The conclusion of obviousness is therefore based upon knowledge available to one of ordinary skill in the art at the time of invention and not upon Applicant’s disclosure. In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
Accordingly, Applicant has not identified reversible error in the articulated rationale supporting the combination of the references, and the rejection under 35 U.S.C. 103 is therefore 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. 68-69). 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 § 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
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
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