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 .
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 1-25 are pending in this application.
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 1-25 are rejected under 35 U.S.C. 103 as being unpatentable over Griebenow et al. (WO 2019/002132 A1 – cited in IDS – previously cited) (“Griebenow”); in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591 – previously cited) (“Meanwell”).
Regarding claims 1-7, 9-12, 19, and 25, 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.; M is O; and R7 is H.
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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, 19, and 25, 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 21-24, 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 1-25 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 and 25, 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 21-24, 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.
Specification
Applicant has failed to acknowledge the objections to the specification. Therefore, the objection to the non-descriptive title is maintained.
Claim Rejections - 35 USC § 112(b)
In view of claim amendments, 35 USC § 112(b) rejections of record have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 07/09/2026 have been fully considered but they are not persuasive.
Applicant argues the backbone of the A moiety is essential for compound activity, and that Griebenow teaches away from the claimed invention because they don’t teach a variable substituent. Applicant argues the rejections of record amount to hindsight-based picking, since Griebenow provides no hint or suggestion that their compound should be varied. Applicant argues that Meanwell does not remedy the deficiencies of Griebenow, since their teaching of bioisosteres is ‘not applicable to the claimed invention’. Applicant argues the skilled person would recognize N-C vs N-N are fundamentally distinct bonds and thus cannot be considered bioisosteric replacements due to electronics, potential effects on molecule conformation, and hydrogen bonding capabilities.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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).
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).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Griebenow discloses their compound of formula (II) below (pages 2-3 and 56), for the treatment, control and/or prevention 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.; and R7 is H.
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(T5-1)
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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, 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. 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.
In response to Applicant’s arguments that Griebenow teaches away from the modification to their compound’s backbone. 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). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)” Griebenow makes not specific mention that changing the nitrogen in their backbone for a carbon is detrimental for activity of their compounds; therefore, Griebenow does not teach away from the modifications cited herein.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In order for Applicant’s arguments to be persuasive, Applicant needs to demonstrate some unexpectedly better activity or property of the instant compounds vs Griebenow’s compounds, backed up by relevant and factual comparative experimental results. Applicant’s opinion that N-N vs C-N bonds are different and therefore the bioisosteric modification is not obvious have no weight on the patentability of the instant compounds and is not persuasive in view of the rejections of record. The rejection is maintained. This action is final.
Double Patenting
Applicant's arguments filed 07/09/2026 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
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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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