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 08/20/2026 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 Claim 26 is withdrawn from consideration.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.
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 filed 08/20/2026 have been fully considered but they are not persuasive.
Applicant is reminded 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 isomerism structural similarity must be considered with all other relevant facts, citing a very specific court case to conclude the following ‘it would not have been reasonably expected that the claimed compounds would have similar properties to Wang’s.’ Applicant asserts the instant compounds differ from Wang’s compounds, however, Applicant provides no real evidence to support this statement. Applicant argues Wang provides no teaching to modify their 5-pyrimidine to the instantly claimed 6-pyrimidine isomer of Wang’s compound.
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 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, 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, 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 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.
In response to Applicant’s arguments that one would have no reason to expect modification of Wang’s compounds would result in the same activity, Applicant is advised that the courts have found 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)). Furthermore, per MPEP 2143.02 (I): Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018) ("This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." (citing to Hoffmann-La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir. 2014); PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1364 (Fed. Cir. 2007); Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute")).
As stated in the last office action, Applicant needs to demonstrate a special property of the instant compounds with 6-pyrimidine substitution at R1 compared to Wang’s 5-pyrimidine isomer in order to overcome the obviousness rejections of record.
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.
Obviousness rejections are maintained in this final action.
Non-Statutory Double Patenting Rejections
Applicant requests the provisional NSDP rejection of record be held in abeyance. The rejection is 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
Prosecution Insights