DETAILED ACTION
All objections and rejections not mentioned below are withdrawn.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/219,167, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicated a lack of support in application 63/219,167 for IA-4, IB-4 and
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. Thus claims 3, 13, 19, 23 received a priority date of 06/21/2022. The remaining claims received a priority date of 07/07/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/22/2024, 11/22/2024, 09/22/2025 and 06/25/2026 are being considered by the examiner.
Claim Interpretation
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The claims are interpretated that cyclic groups can include oxo groups that are unsaturated and substituent this is supported by both the claims and the specifications. For example see the following example from the specification (page 11) and claim 31:
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Additionally, as the specification does not specify what compounds of claim 1 would be included as IRAK4 binding moiety it is assumed that all compounds of formula (I) and Formula (A) are enabled for IRAK4 binding and degradation. As no specific structure other than the instant formula is taught to accomplish the specific biological activities of the claims the claims are interpreted so that any structure of the instant claim is understood to inherently possess that biological activity.
Claim Rejections - 35 USC § 103 -Updated due to Amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over MAINOLFI (MAINOLFI et al., WO2020264499A1, 2020-12-30, IDS).
The reference MAINOLFI teaches the following compound I-385 (page 432), wherein, B1=C, B2=N, R2=H, A1=CR3, A2=CH, R3=OR6, R6=C2 alkyl substituted with R6a= C1 alkyl, R1=6- membered heteroaryl having 1 N, substituted with one R5, R5= C1 alkyl substituted with 3 halo, L =
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, DSM=
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or
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, Y=CRD1, RD1=H, Z1=bond, G1=
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(see instant claim 31), G2=NRD4-Het1=6 membered monocyclic heterocycle or Het1, RD4=C1 alkyl, (L-2), G3=C6 cycloalkyl , Z3=C1 alkyl.
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This helps to teach claim 54.
The reference also teaches “Provided compounds are degraders and/or inhibitors of one of more of IRAK-1, IRAK- 2, and/or IRAK-4 and are therefore useful for treating one or more disorders associated with activity of one or more of IRAK-1, IRAK-2, and/or IRAK-4. Thus, in certain embodiments, the present invention provides a method for treating a IRAK-1-mediated, a IRAK-2-mediated, and/or a IRAK-4-mediated disorder comprising the step of administering to a patient in need thereof a compound of the present invention, or pharmaceutically acceptable composition thereof” [00670] and “ Diseases and conditions treatable according to the methods of this invention include, but are not limited to, cancer…”[00673].
The reference MAINOLFI also teaches (pages 29-30):
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The reference MAINOLFI has been discussed supra (and is incorporated by reference herein) and does not disclose a specific compound of claim 54 and instead requires picking and choosing from among variables to produce a compound of claim 54.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified MAINOLFI to get a compound of instant claim 54 because the only difference between lead compound I-385 and instant compound 42 is the positions of 2 nitrogens in the IRAK4 binding moiety and the lead compound would be obvious to modify to get this change in nitrogen positions because pages 29-30 specifically teach the needed change.
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One would have a reasonable expectation of success because the desired moiety is specifically suggested in the alternative and one would be motivated to do so because all the compounds of the generic formula of the reference are suggested to treat diseases associated with IRAK.
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Allowable Subject Matter
Claims 1, 3, 12-13, 15, 19, 23, 55, 56 are allowed.
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive. The applicant argues “With respect to claim 54, the Examiner acknowledges that Mainolfi 2020 "does not disclose a specific compound of claim 54 and instead requires picking and choosing from among variables to produce a compound of claim 54." However, the Examiner alleges that this selection would be obvious. Applicant disagrees, and submits this is only obvious with improper hindsight. That is, that there is no suggestion or motivation in Mainolfi 2020 to "pick and choose" the specific IRAK, L, and DSM groups (or IRAK, L, DIM group in Mainolfi 2020) of the instant claims, and combine them in such a way to arrive at the instant compounds in claim 54. In addition, the majority compounds of instant claim 54, do not comprise the DSM group having the following ring structures of Mainolfi 2020…Almost all of the exemplified compounds in Mainolfi 2020 have these groups as part of their DSM group, and there is no suggestion or motivation in Mainolfi 2020 to modify this group and arrive at the specific DSM groups in the instantly compounds of claim 54. Nor is there any reasonable expectation that such modifications would lead to compounds with maintained IRAK degradation activity. Thus, Applicant submits that the instant claims are non-obvious over Mainolfi 2020”.
This argument is not considered persuasive. 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). The only difference between the reference compound:
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And instant compound 42:
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Is the position of one nitrogen atom in the fused ring. The knowledge to make this change would be obvious to one of ordinary skill in the art because such a change is suggested by the reference and thus is proper hindsight reasoning. The reference MAINOLFI teaches (pages 29-30):
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There is reasonable motivation and expectation that the reference would lead to compound 42 of the instant claims because the required modification is suggested; and would maintained IRAK degradation activity because it is a suggested alternative by the reference. 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).
Conclusion
Claim 54 is rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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