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 .
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 9th, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 9th, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 1, 6-7, 18-21, and 23-26 are pending in this application. Claims 2-5, 8-17, 22, and 27-58 have been cancelled by applicant. Claims 1, 6-7, 18-21, and 23-25 are under examination herein. Claim 26 is withdrawn from consideration.
Allowable Subject Matter
Claims 23-24 are allowed.
Examiner Notes
Claims 19-20 are free of the prior art, but stand rejected over a provisional NSDP rejection – see response to arguments section at the end of this non-final office action.
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, 6-7, 18, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2015/137887 A1 – cited in IDS – previously cited) (“Wang”).
Regarding claim 1, Wang teaches compound Ib below (pages 25-30), as useful for the treatment of neurological disorders, which is the same as the instantly claimed intended use (page 5, lines 5-6). Wang’s compounds render the instant compounds obvious when: R1 is morpholino; R4 (corresponding to instant RA) is H or alkyl; R3 (corresponding to instant R2) can be pyrrolidine or piperidine (page 26, para. 2); R2 (corresponding to instant R1) can be optionally substituted heteroaryl, specifically mentioning pyrimidinyl,
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Wang specifically discloses the compound below as a preferred embodiment, which reads on the instant claims when R2 is a substituted heterocycle and RA is alkyl (pages 38 and 48).
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While Wang’s preferred embodiment shows pyrimidin-5-yl substitution in the position corresponding to instant R1, instead of pyrimidin-6-yl as claimed, Wang’s teaching that their R2 group can be pyrimidines would have led one of ordinary skill to explore the limited number of connectivities available for pyrimidine and the core of Wang’s compound. Furthermore, Wang discloses their compounds for the treatment of neurodegenerative or neurological conditions, which is the same use claimed in the instant invention (page 51, para. 1). Therefore, Wang discloses a fairly narrow subgenus, which overlaps with the instantly claimed genus of compounds.
Therefore, regarding instant claim 1, one having ordinary skill would have found the claimed compounds prima facie obvious, since they are generically embraced by Wang’s disclosed formula Ib and the preferred embodiment shown above. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Wang, suitable for the treatment of neurological conditions. 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.
Applicant is advised that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Regarding claim 6, Wang discloses their compounds of Formula Ib wherein the group corresponding to instant RA can be C1-6 alkyl.
Regarding claim 7, Wang discloses their compounds of Formula Ib wherein the group corresponding to instant RA can be H.
Regarding claim 18, Wang discloses their compounds of Formula Ib wherein the group corresponding to instant R1 can be pyrimidine.
Regarding claim 21, Wang discloses their compound above, wherein the group corresponding to instant R2 is a substituted piperidine.
Regarding claim 25, Wang discloses a pharmaceutical composition comprising their compounds and an acceptable excipient (Wang’s claim 45).
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, 6-7, 18-21, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 10, 14, 21, 25-26, 28, 30-31, 259, and 335 of copending Application No. 18/717,174 (Copending ‘174). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 6-7, 18-21, and 25, Copending ‘174 claims the compounds of Formula 1 and 1a below, which anticipate the instant claims when RA can be H, alkyl, C6-10 aryl, etc.; R1 (corresponding to instant R1) can be pyrimidine, pyrazole, etc.; and R2 (corresponding to instant R2) can be aryl, heteroaryl, heterocycle, etc. (Copending ‘174’s claims 1 and 30).
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been added.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 14-16, filed April 9th, 2026, with respect to 35 USC § 103 rejections of the claims over Castanedo ’08; Castanedo ’09 have been fully considered and are persuasive. In light of the claim amendments, the 35 USC § 103 rejections of the claims over Castanedo ’08; Castanedo ’09 have been withdrawn. Rejections in view of Wang are maintained as outlined herein.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
Applicant argues that the fact the present claims are encompassed by Wang does not, by itself, render the claims obvious, and that there must be a reason or motivation to both select and modify the prior art compounds in the particular manner required to arrive at the claims. Applicant cites a “two-prong inquiry” that would lead one of ordinary skill to select a lead compound and modify with a reasonable expectation of success. Applicant states that Wang discloses over 105 exemplified compounds and thousands encompassed by their genus. Applicant states Examiner provides no evidence as to why one of ordinary skill would have selected compound 86 as a starting point for modifications. Applicant asserts that compound 86 is not a lead compound and that it is the only one with the ring systems at R1 and R2 as claimed, and that it has lower activity compared to other compounds. Applicant states that, since compound 86 was the only exemplified compound with ring systems as the positions corresponding to R1 and R2, there is no reason why one skilled in the art would have been motivated to select this compound as the starting point for modification with a reasonable expectation of success.
In response to applicant’s argument that there is no teaching, suggestion, or motivation in the references, the examiner recognizes that obviousness may be established by 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, Wang teaches compound Ib below (pages 25-30), as useful for the treatment of neurological disorders, which is the same as the instantly claimed intended use (page 5, lines 5-6). Wang’s compounds render the instant compounds obvious when: R1 is morpholino; R4 (corresponding to instant RA) is H or alkyl; R3 (corresponding to instant R2) can be pyrrolidine or piperidine (page 26, para. 2); R2 (corresponding to instant R1) can be optionally substituted heteroaryl, specifically mentioning pyrimidinyl,
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Wang specifically discloses the compound below as a preferred embodiment, which reads on the instant claims when R2 is a substituted heterocycle and RA is alkyl (pages 38 and 48).
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While Wang’s preferred embodiment shows pyrimidin-5-yl substitution in the position corresponding to instant R1, instead of pyrimidin-6-yl as claimed, Wang’s teaching that their R2 group can be pyrimidines would have led one of ordinary skill to explore the limited number of connectivities available for pyrimidine and the core of Wang’s compound. Furthermore, Wang discloses their compounds for the treatment of neurodegenerative or neurological conditions, which is the same use claimed in the instant invention (page 51, para. 1). Therefore, Wang discloses a fairly narrow subgenus, which overlaps with the instantly claimed genus of compounds.
Therefore, in response to Applicant’s argument about motivation, expectation of success, and the two prong inquiry - one having ordinary skill would have found the claimed compounds prima facie obvious, since they are generically embraced by Wang’s disclosed formula Ib and the preferred embodiment shown above. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Wang, suitable for the treatment of neurological conditions. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, with a reasonable expectation of success.
Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph). Specifically, in the present case, Wang’s preferred embodiment differs from the instant claims only in the connectivity to the pyrimidine corresponding to instant R1. Wang discloses their compound for the same intended use as the instant application, therefore, in order for Applicant’s arguments to be persuasive, Applicant needs to demonstrate that Wang’s compounds with pyrimidin-5-yl connectivity, are somehow inferior to the instantly claimed compounds with R1 being pyrimidin-6-yl.
In response to Applicant’s arguments that Wang discloses many compounds and a broad genus, and that only one of their compounds corresponds to the instant R1 and R2 selections, and that compound 86 is not as potent as others in Wang and therefore one of ordinary skill would not have elected this compound; Applicant is advised that, per MPEP 2123 (I) and (II): The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Furthermore, 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); and "[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).
Non-Statutory Double Patenting Rejections
Applicant's arguments filed April 9th, 2026 have been fully considered but they are not persuasive.
Applicant requests that obviousness-type non-statutory double patenting rejections over US Application No. 18/717,172 and 18/717,174 be held in abeyance until the application is in condition of allowance.
Claims stand rejected over obviousness-type non-statutory double patenting rejections over US Application No. 18/717,174.
Upon further consideration, the obviousness-type non-statutory double patenting rejections over US Application No. 18/717,172 has been withdrawn.
Applicant is advised: MPEP § 804(1)(B)(1)(b)(i) states, if a provisional NSDP rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
In the instant case, Copending ‘174 has an effective patent term date of 12/07/2022, while the instant application has an effective pated term date of 06/03/2021. Therefore, after all other pending issues are resolved, this provisional NSDP rejection will be withdrawn.
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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