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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30th, 2026 has been entered.
Examiner Notes
The Examiner would like to apologize for indicating allowable claims in the final rejection mailed 04/01/2026 – Upon further consideration, new rejections are presented in this non-final office action.
Information Disclosure Statement
While the Wang et al. reference cited in the rejections presented herein is cited in the IDS filed 12/31/2022, an NPL of the English translation of the description of WO2020147798A1, obtained from Espacenet, is cited and included herein.
Status of the Claims
Claims 2, 4, 6, and 12-23 are pending in this application. Claims 1, 3, 5, and 7-11 have been cancelled by Applicant.
Claim Objections
Claim 2 is objected to because of the following informalities: the structure
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is blurry and difficult to read.
Appropriate correction is required.
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 2, 4, 6, 12-19, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2020/147798 A1 – Int. Filing Date: Jan. 16th, 2020 – cited in IDS) (“Wang”).
Regarding instant claims 2, 4, 12-19, and 22-23, Wang discloses their compounds of Formula A as BTK inhibitors (page 1 of translated doc.; and Abstract) – which is the same intended use as the instant application. Wang’s compounds read on the instant claims when A-B fused ring system is
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(page 3, lines 8-9); and wherein L-1-Cyc1-L2-Cyc2 is
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or
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(page 2, lines 25 and 30), as in their preferred embodiments of Formula B and C below, which read on instant X being
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. Also, embodiments where instant X is
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and
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are obvious, since compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -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 MPEP 2144.09.
Furthermore, Wang specifically discloses their
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in Formulae B and C can be
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(page 4, lines 6-10). Wang also teaches their R12-15 can be H, halogen, substituted or unsubstituted C1-C6 alkyl, etc. (page 2, bottom, of translated doc.).
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(B)
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(C)
Wang specifically discloses their preferred embodiment below (page 60), which reads on the instant compounds when m = 0; n = 1; X is -O-; R6 is H; and R8 is F, -OMe, and H. While Wang’s preferred embodiment differs in the arrangement of the nitrogens of the bicyclic core, Wang specifically discloses their A-B fused core can be
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(page 3, lines 8-9), which corresponds to the core of the instant compounds when R1 is amino and R2 is H.
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Therefore, regarding claims 2, 4, 12-19, and 22-23, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Wang’s disclosed formulae and preferred embodiments; 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 BTK inhibitor compounds disclosed by Wang. 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 4, the compounds below, for example, are particularly obvious in view of Wang’s disclosure.
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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 pharmaceutical compositions comprising their compounds and an acceptable carrier (page 7, line 9 of translated doc.).
Claims 2, 4, 6, and 12-23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (WO 2020/147798 A1 – Int. Filing Date: Jan. 16th, 2020) (“Wang”); as applied to claims 2, 4, 6, 12-19, and 22-23; in view of Meanwell et al. (J. Med. Chem. 2011, 54, 2529–2591) (“Meanwell”).
The teachings of Wang are disclosed above and incorporated herein.
While Wang does not teach their compounds wherein R9 and R13 are H; the teachings of Meanwell are relied upon for these disclosures.
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 teaches -O- and -CH2- as classical divalent bioisosteres (Table 1).
Therefore, regarding claims 2, 4, and 12-23, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Wang’s disclosed formulae and preferred embodiments 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 BTK inhibitor compounds disclosed by Wang; in view of Meanwell’s teachings that the design of bioisosteres leads to optimization of lipophilicity, potency, etc. in lead compounds and drugs. Accordingly, one having ordinary skill in the art would have been motivated to replace the -O- in Wang’s compounds for
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, wherein R9 and R13 are H to arrive at the instant invention.
Further regarding claim 4, the compound below, for example, is particularly obvious in view of Wang’s disclosure, since their R12-13 (corresponding to instant R8) can be H.
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Regarding claim 6, Wang discloses pharmaceutical compositions comprising their compounds and an acceptable carrier (page 7, line 9 of translated doc.). Therefore, it would have been obvious to one of ordinary skill to prepare pharmaceutical compositions comprising the instant compounds in which X is
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.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 112(b)
In view of claim amendments, the 35 USC § 112(b) rejections have been 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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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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