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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/17/2025 and 01/16/2026 were filed after the mailing date of the non-final on 10/02/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Status of the Claims
Claims 1-23 are pending in this application.
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 11, 13-18, and 21-23 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 13 is indefinite because it references structure Ia-5’’, however this structure is not provided in the claims. There is insufficient antecedent basis for this limitation in the claim. As stated in MPEP 2173.05(s), claims should be complete to themselves and the reference to tables and figures in the spec. renders the claims incomplete. For the purposes of applying art, it will be assumed Applicant intended the structure below, found in page 58 of the instant spec.
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Claims 14-18 are rejected for depending upon the limitations of claim 13.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “R7 is… C1-C9 alkyl”, and the claim also recites “optionally…nonyl” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 21 recites the limitation "and/or a pharmaceutical composition comprising the compound of Formula I’ according to claim 1". There is insufficient antecedent basis for this limitation in claim 1, which discloses only the compounds of Formula I’ “and/or a stereoisomer and/or salt thereof.”
Claims 22-23 are rejected for depending upon the limitations of claim 21.
Claim Rejections - 35 USC § 103
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.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Griebenow et al. (WO 2019/002132 A1 – cited in IDS) (“Griebenow”); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
Regarding claims 1-7, 9-12, and 19, Griebenow discloses their compound of formula (II) below (pages 2-3 and 56), for the treatment, control and/or prevention of diseases, in particular of helminth infections – which is the same intended use as the compounds in the instant application.
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, wherein T can be:
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(page 3, line 10)
Griebenow’s discloses their preferred embodiments T5-1 and T1-5, for example (pages 173 and 187), which read on instant formula (I) when instant Y-2 is O; Z1-4 are CH; X1, 5-6 are N or CH; X4 is CR4, wherein R4 is -N(CH3)2 or N-heterocycle; and Q is aryl (phenyl) substituted with halogens, etc.
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(T5-1)
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While Griebenow does not disclose their compounds having a nitrogen in the position adjacent to instant Y0 and G in Formula I’; the teachings of Meanwell are relied upon to leverage these differences.
Meanwell teaches that the design of bioisosteres frequently introduces structural changes that can be beneficial depending on the context, with size, shape, electronic distribution, polarizability, dipole, polarity, lipophilicity, and pKa potentially playing key contributing roles in molecular recognition and mimicry. In the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates (abstract). Meanwell specifically teaches R3CH and R3N as classical trivalent bioisosteres (Table 1, page 2530).
Therefore, regarding claims 1-7, 9-12, and 19, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Griebenow’s disclosed formula in view of Meanwell; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds for the treatment of helminth infections disclosed by Griebenow; further in view of Meanwell’s disclosure that the design of bioisosteres introduces structural changes that can improve polarity, lipophilicity, and pKa, potentially playing key contributing roles in molecular recognition and mimicry, and their teaching that R3CH and R3N as classical trivalent bioisosteres. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Further regarding claim 19, Griebenow’s preferred embodiments above read on the instant compounds below:
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Regarding claim 8, while Griebenow does not disclose preferred embodiments wherein their Q group (corresponding to instant Q) is a heteroaryl, they do disclose their Q may be a 5-10 membered heteroaryl, optionally substituted with 1-5 halogens, etc. (page 9, lines 8-10).
Regarding claims 13-18, Griebenow discloses their preferred embodiment T5-1 above, in which the group corresponding to R1 is H; R4 is
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; R11 is H; Q is phenyl substituted with halogens – specifically
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.
Regarding claim 20, Griebenow claims a pharmaceutical composition comprising their compounds and acceptable excipients (Griebenow’s claim 12).
Regarding claims 21-23, Griebenow claims their compounds for use in the treatment or prevention of helminthic infections; specifically disclosing heartworm disease (Griebenow’s claims 13-15; abstract; and page 1, para. 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Griebenow’s compounds in view of Meanwell for the treatment of helminthic infections, such as heartworm disease. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Griebenow in view of Meanwell’s disclosure of the instant compounds and pharmaceutical compositions thereof, as effective in the treatment of helminthic infections and heartworm disease.
Applicant is advised that the courts have found that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of US Patent No. 12,448,391 (US ‘391) (previously cited as copending Application No. 17/616,436 (Copending ‘436)). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-20, US ‘391 claims the compounds of Formula I below and pharmaceutical compositions thereof, wherein G can be
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and Q, X1-6, Z1-4, and Y1-2 are defined as in instant claim 1, thus anticipating the instant claims when instant Y0 is -CH-2- (US ‘391’s claims 1 and 23).
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Regarding instant claim 13-18, US ‘391 claims the compound of Formula Ia-5 below (US ‘391’s claims 14-19), thus anticipating the instant claims.
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Regarding claim 19, US ‘391 claims the same compounds (US ‘391’s claim 20), thus anticipating the instant claims when the group corresponding to instant Y0 is -CH-2-, for example, the compounds below are claimed in both applications:
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Regarding claims 21-23, US ‘391 claims their compounds as part of products for the treatment of heartworm (US ‘391’s claims 25-27).
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 112(a)
Applicant’s arguments, see page 40, filed 02/02/2026, with respect to 35 USC § 112(a) rejections of the claims have been fully considered and are persuasive. The 35 USC § 112(a) rejections of the claims has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see page 40-41, filed 02/02/2026, with respect to 35 USC § 103 rejections of the claims have been fully considered and are persuasive. The 35 USC § 103 rejections of the claims has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Griebenow in view of Meanwell.
These rejections were not necessitated by Applicant’s amendment, as such, this action is non-final.
Double Patenting
Applicant's arguments filed 02/02/2026 have been fully considered but they are not persuasive.
Applicant states they’ll consider filing a terminal disclaimer upon indication of allowable subject matter. Therefore, the non-statutory double patenting rejections of record are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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