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 .
DETAILED ACTION
This Office action is in response to applicant’s amendment and arguments filed on August 14, 2025, in which claims 1, 8, 10, 12, 13, 23, and 24 are amended.
Claims 1-25 are pending in the instant application, and are examined on the merits herein.
Priority
This application is a National Stage entry of PCT/EP2020/076134, filed on September 18, 2020, and claims priority to India foreign application IN202011033968 filed on August 7, 2020, and EPO foreign application EP19198814.6 filed on September 20, 2019. A certified copy of the foreign priority documents in English have been received.
Objections/Rejections Withdrawn
The objection of claims 23 and 24 for informalities are withdrawn in view of the amendment removing the extraneous closing parenthetical mark. This objection is withdrawn.
The rejection of claim 5 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second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter, is withdrawn as the claim does not encompass the scope of claim 1 that rendered the claim indefinite. This rejection is withdrawn.
The rejection of claim 8 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second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter, is withdrawn as the claim has been amended to remove the parenthetical marks. This rejection is withdrawn.
The rejection of claims 23 and 24 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second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter, is withdrawn as the claims have been amended to remove the “such as” language. This rejection is withdrawn.
The rejection of claim 12 under 35 U.S.C. 102(a)(1), as being anticipated by Ando (Bioorg. Med. Chem.), is withdrawn in view of the amendment to the claim scope removing the propyl moiety in the Markush group of Rx. This rejection is withdrawn.
Claim Objections
Claim 15 is objected to because of the following informalities: The comma after the second heteroaryl at the last line of page 8 should be deleted so the limitation reads “heteroaryl substituted with 1 to 3 independently selected substituents R6”. Appropriate correction is required.
The following are maintained or new grounds of rejections necessitated by Applicant’s amendment to the claims.
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 1-4, 6-11, 13, and 14 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 1 recites “heteroaryl (which is either a 5 or 6 membered monocyclic or a 9 or 10 membered bicyclic),” and also recites “heteroaryl (which is either a 5 or 6 membered monocyclic or a 9 or 10 membered bicyclic) substituted with 1 to 3 independent selected substituents…” for the R4 variable. It is unclear if the parenthetical phrase is limiting.
Claims 2-4, 6-11, 13, and 14 are rejected for depending from a rejected.
Response to Arguments
Applicant’s amendment and arguments, with respect to the rejection of claims 1-4, 6-11, 13, and 14 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, has been carefully considered, but are not persuasive. As indicated in the rejection above, there is still an instance of parenthetical language that was not corrected by amendment.
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ando et al. (IDS dated 3/17/2022).
Ando discloses the compound 29a, propyl 6-[(4-methoxybenzyl)oxy]-5-(trifluoromethyl)- pyridine-3-carboxylate (29a) (p. 6109, Scheme 5; p. 6120, left column, section 5.2.55). This compound corresponds to compound VI-a, wherein R1 is C1 haloalkyl, R3 is H, and R5 is C1-alkoxy. Compound 29a differs from the instantly claimed compound of VI-a, in that it does not teach that Rx is a methyl, ethyl, isopropyl, butyl, iso-butyl, or tert-butyl. Rather, it teaches the corresponding Rx moiety is a propyl group, which is not within the claim scope.
Nevertheless, in light of Ando teaching compound 29a, in which the corresponding Rx moiety is a propyl group, the methyl, ethyl, or butyl groups would have been prima facie obvious because one of ordinary skill in the art would expect the compounds to behave similarly. Specifically, MPEP 2144.09(II) states that compounds which are…homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ando et al. (IDS dated 3/17/2022), in view of Wuts (PTO-892).
Ando discloses the compound 29a, propyl 6-[(4-methoxybenzyl)oxy]-5-(trifluoromethyl)- pyridine-3-carboxylate (29a) (p. 6109, Scheme 5; p. 6120, left column, section 5.2.55). As set forth in Scheme 5 (p. 6109), compound 29a is derived from compound 28a by reacting compound 28a with Pd(OAc)2, dppf, Et3N, n-PrOH, DMF, CO gas, at 100 °C. As further shown in the reaction scheme, the n-Pr moiety of the carboxylic acid serves as a protecting group as it is removed in the next step to yield compound 30 or 31. Compound 29a corresponds to compound VI-a, wherein R1 is C1 haloalkyl, R3 is H, and R5 is C1-alkoxy.
Compound 29a differs from the instantly claimed compound of VI-a, in that it does not teach that Rx is a methyl, ethyl, isopropyl, butyl, iso-butyl, or tert-butyl. Rather, it teaches the corresponding Rx moiety is a propyl group, which is not within the claim scope.
Wuts teaches the protection of the carboxyl group, providing general preparation and cleavage of esters, as well as more specific carboxyl protecting groups. Wuts teaches that the carboxylic acids are protected for a numbers of reasons, including to mask the acidic proton so that it does not interfere with base-catalyzed reactions, to mask the carbonyl group to prevent nucleophilic addition reactions, and to improve the handling of the molecule in question (p. 537, first paragraph). General preparation procedures for esters are provided at p. 538-543. Methyl ester formation and deprotection is disclosed at p. 553-559. T-Butyl ester formation and cleavage is disclosed at p. 582-586.
Thus, it would have been prima facie obvious for one of ordinary skill in the art to substitute the propyl ester protecting group of compound 29a, as disclosed by Ando, with a methyl or tert-butyl ester protecting group, of Wuts, because each are taught to be useful for protection of carboxylic acids. One of ordinary skill in the art would have a reasonable expectation of success because each are taught to be useful for protecting a carboxylic acid moiety, and Ando specifically show in Scheme 5 that the propyl moiety is used as a protecting group for the carboxyl group in showing the conversion of compound 29a to compound 30 or 31..
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 1-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/553,466 (reference application) (hereinafter ‘466).
Although the claims at issue are not identical, they are not patentably distinct
from each other because the claims of ‘466 are drawn to a structure of formula (I), and a method of its use in combating and controlling insects, acarines, nematodes, or molluscs, for the protection of plant propagation material from the attack by insects, acarines, nematodes, or molluscs, or of controlling parasites in or on an animal in need thereof. The claims of ‘466 are also drawn to compounds of formula III-a, V-a, and VI-a.
The instant claims are drawn to a compound of formula (I), and and a method of its use in combating and controlling insects, acarines, nematodes, or molluscs, for the protection of plant propagation material from the attack by insects, acarines, nematodes, or molluscs, or of controlling parasites in or on an animal in need thereof. The instant claims are also drawn to compounds of formula III-a, V-a, and VI-a. The instant claims are also drawn to compounds of formula III-a, III-b, VI-a, and VI-b.
The identified structures have identical core molecules between the reference patent application and that of the instant application, specifically wherein Z is O, and there is significant overlap between the Markush limitations for the different variables. Thus, the instant claims are found to be patentably indistinct from those of ‘466.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/555,344 (reference application) (hereinafter ‘344).
Although the claims at issue are not identical, they are not patentably distinct
from each other because the claims of ‘344 are drawn to a structure of formula (I), and a method of its use in combating and controlling insects, acarines, nematodes, or molluscs, for the protection of plant propagation material from the attack by insects, acarines, nematodes, or molluscs, or of controlling parasites in or on an animal in need thereof.
The instant claims are drawn to a compound of formula (I), and and a method of its use in combating and controlling insects, acarines, nematodes, or molluscs, for the protection of plant propagation material from the attack by insects, acarines, nematodes, or molluscs, or of controlling parasites in or on an animal in need thereof. The instant claims are also drawn to compounds of formula III-a, V-a, and VI-a. The instant claims are also drawn to compounds of formula III-a, III-b, VI-a, and VI-b.
The identified structures have identical core molecules between the reference patent application and that of the instant application, more specifically wherein Z is O, and there is significant overlap between the Markush limitations for the different variables. Thus, the instant claims are found to be patentably indistinct from those of ‘344.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, with respect to the provisional rejection of claims 1-25 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/553,466, and independently over claims 1 –11 of copending Application No. 18/555,344, have been carefully considered, but are not persuasive.
Applicant argues that the ‘466 and ‘344 applications have a patent term filing date that is later than that of the instant application, and thus, according to MPEP 804.I.B.1(b)(i), if this is the only rejection remaining, it should be withdrawn. Since the nonstatutory double patenting rejections are not the only rejections remaining, applicant’s arguments are not persuasive. The rejections are still maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SCARLETT Y GOON whose telephone number is (571)270-5241. The examiner can normally be reached M-F 9:00am - 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at (571) 272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCARLETT Y. GOON/
Supervisory Patent Examiner
Art Unit 1693