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 .
DETAILED ACTION
Status of 18/293,823
Claims 1, 4-5, 7-11, 13, 17, 21, 23, 34-35, and 42-46 are currently pending.
Priority
Instant application 18/293,823, filed 1/31/2024, claims priority as follows:
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The effective filing date of a claimed invention is determined on a claim-by-claim basis. See MPEP § 2152.01.
The priority document U.S. Provisional Application No. 63/231,156 fails to provide support under 35 U.S.C. 112 for when Z of instant Formula (I) is NRx. Thus, the instant claims are not entitled to the effective filing date of 8/9/2021. However, the document PCT/US2022/039674 contains support for the limitation of where Z is NRx, and the claims are granted the effective filing date of 8/8/2022.
Information Disclosure Statement
All references from the IDS submitted on 12/4/2024 have been considered unless marked with a strikethrough. The Examiner notes Cite No. 155 is a repeat reference, and the content of Cite No.’s 225 and 265 are pixelated and illegible, and thus cannot be fully considered. The other references struck through are not present in the file wrapper.
Election/Restriction
Applicant’s election of Group I, claims 1, 4-5, 7-11, 13, 17, 21, 23, 34-35, and 42-45, drawn to compounds and compositions of Formula (I), without traverse in the reply filed 4/22/2026 is acknowledged. Applicant’s election of compound 4:
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In the same reply, without traverse, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and no prior art was identified. The search was expanded to the full scope of Formula (I), and no prior art was identified. However, additional rejections were identified within Group I. Claims 1, 4-5, 7-11, 13, 17, 21, 23, 34-35, and 42-45 are thus the subject of this Office Action. Claim 46 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 10, 34-35, and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 8 and 10 recite the limitation where R1B is absent. Without the variable R1B attached to the aryl ring, the broadest reasonable interpretation of where R1B is absent includes an anion on the aryl ring, which is not included by Formula (I). Thus, this limitation is indefinite. Dependent claims 34-35 do not resolve this issue by claiming a compound where R1B is absent and are therefore also rejected. Appropriate correction is required. The Examiner notes this rejection could be overcome by amending the claims to recite where R1 and R1B can be hydrogen.
Claim 44 recites references to tables in the claim, found in the specification of the application. According to MPEP § 2173.05(s), claims should be complete and should not incorporate figures or tables by reference unless absolutely necessary. Incorporation by reference is a necessity doctrine, not a convenience for the Applicant. Appropriate correction is required.
Claim Objections
Claim 1 is objected to for a minor informality. With reference to R2, claim 1 recites, “haloalkyl, C3-C6 cycloalkyl”, but should read, “haloalkyl, or C3-C6 cycloalkyl”. Appropriate correction is required.
Claims 4-5, 7, 9, 11, 13, 17, 21, 23, 42-43, and 45 are objected to as being dependent upon a non-allowable base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Close Prior Art Not Cited
Close prior art identified during the search is Scorpion Therapeutics, Inc. (WO 2022/265993 A1, cited in the IDS of 12/4/2024, herein after “Scorpion 1”), which is drawn to PI3K inhibitors of Formula (I):
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Which partially overlaps with instant Formula (I):
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By the variables R1, m, Z, R2, and R3. The variable A of Scorpion 1 can be a 6-10 membered aryl, a C3-C8 cycloalkyl, a 5-10 membered heteroaryl, or a 4-10 membered heterocyclyl and the variable R4 can be a variety of substituents that overlap with the R4 of the instant claims. However, the main difference in the compounds of Scorpion 1 is the internal urea attached to ring A, whereas the instant claims contain an amine attached to an imidazole.
Additional close prior art is Hranjec (Hranjec, M. et. al. Eur. J. Med. Chem., 2013, 59, 111-119), which is drawn to benzofuran-2-carboxamides with antiproliferative effects (abstract). Specifically, Hranjec teaches benzofuran-amide-benzimidazole compounds 6b, 6d, and 6f (page 113, Figure 2):
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which partially map to instant Formula (I):
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When m is 0, Z is O, X1 is CH, X2 is CH, X3 is CRx, and X4 is CH. Furthermore, compounds 6b, 6d, and 6f of Hranjec demonstrated antiproliferative effects on human tumor cell lines, in addition to control cell lines (page 114, Table 1). The compounds of Hranjec do not contain a substituent at the 3-position of the benzofuran, as defined as R2 in instant Formula (I). Furthermore, Hranjec contains a carbonyl at the R3 position, which the instant claims do not allow, and the compounds of Hranjec contain CN, NO2, and an imidazoline salt as the variable R, whereas instant Formula (I) does not allow these substituents by the variable R4.
Finally, close prior art not cited is Xia (Xia, J. et. al. J. Chem. Inf. Model. 2018, 58, 1104-1120), which is drawn to virtual screening of small molecules able to target human chemokine receptors (abstract). Xia teaches the following compound (page 1114, Table 3):
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Which partially maps to instant Formula (I):
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When m is 0, R2 is C1 alkyl, Z is O, X1 is CH, X2 is CH, X3 is CH, and X4 is CH. The compound of Xia contains a carbonyl at the R3 position of instant Formula (I), which the instant claims do not allow. Additionally, the compound of Xia is active against human chemokine receptors, not the target of the instant claims.
Conclusion
Claims 8, 10, 34-35, and 44 are rejected. Claims 1, 4-5, 7, 9, 11, 13, 17, 21, 23, 42-43, and 45 are objected to. Claim 46 is withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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