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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/2/2026 has been entered.
Current Status of 18/120,326
Claims 1, 28-31, 33, 58-60, and 63 are currently pending.
Priority
The instant application 18/120,326, filed 3/10/2023, claims priority as follows:
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The provisional application contains support for the claims, and thus the instant claims are granted the effective filing date of 3/14/2022.
Information Disclosure Statement
All references from the IDS’s submitted on 11/26/2024 and 3/26/2026 have been considered unless marked with a strikethrough.
Response to Arguments/Amendments
The amendment filed 2/2/2026 has been entered. Applicant has amended claims 1, 28-29, 33, and 58-60 and has cancelled claims 2-27, 32, 34-57, and 61-62. Claim 63 has been added but is not considered new matter.
In the Final Rejection dated 4/3/2025, claims 6, 8-11, 28, 41, and 48 were objected to because they were dependent on a rejected base claim. In response, Applicant has cancelled the claims, which overcomes the objection. Thus, the objection is withdrawn.
Claims 18-22 and 25 were rejected in the Final Rejection dated 4/3/2025 under 35 U.S.C. 112(b). In response, Applicant has cancelled the claims, which overcomes the rejection. Thus, the rejection is withdrawn.
In the Final Rejection dated 4/3/2025, claims 35-37, 39-40, 42, 44-47, 49, and 52-55 were rejected under 35 U.S.C. 103. In response, Applicant has cancelled the claims, which overcomes the rejection. Thus, the rejection is withdrawn.
Claims 1-2, 5, 7, 12-17, 19, 22-27, 29, 32-34, and 54-55 were rejected under 35 U.S.C. 103 in the Final Rejection dated 4/3/2025. In response, Applicant has cancelled claims 2, 5, 7, 12-17, 19, 22-27, 32, and 34, and amended claim 1 to solely recite:
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The Examiner emphasizes that the claim now recites Formula (I), where X1 and X3 are each CR9, wherein R9 is hydrogen, X2 is N, R7 is trifluoromethyl, and R8 is chloro. Stated differently, Applicant has amended the instant claims to require that the right-handed aryl be a 2-chloro-4-(trifluoromethyl)pyridine. Additionally, Applicants argues that upon the amendments to the claims, a prima facie case of obviousness no longer exists in view of the references You and Propellon. Applicants arguments have been considered, and are persuasive because You does not teach –(CH2)m- when Y is -C(O)- and fails to teach the 2-chloro-4-(trifluoromethyl)pyridine piece of Formula (I). You also fails to teach the compounds of claims 58-60 and 63. Though Propellon teaches the 2-chloro-4-trifluoromethyl(pyridine) moiety in a compound, the compound is in an intermediate. Propellon fails to teach the 2-chloro-4-(trifluoromethyl)pyridine moiety in a final compound tested in MLL1-WDR5 protein-protein interaction inhibitory assays. Further, Applicant’s biological data demonstrating superior results of the instant claims are considered persuasive. This overcomes the rejection of claims 1-2, 5, 7, 12-17, 19, 22-27, 29, 32-34, and 54-55 under 35 U.S.C. 103, and thus, the rejection is withdrawn.
Claims 1-5, 7, 12-17, 19, 21-27, 29, 32-37, 39-40, 42, 44-47, 49, 52-55, and 58-62 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No. 18/120,318 (herein after the ‘318 application) in view of Propellon Therapeutics (U.S. Patent App. Pub. US 2019/0119264 herein after “Propellon”). In response, Applicant has cancelled claims 2-5, 7, 12-17, 19, 21-27, 32, 34-37, 39-40, 42, 44-47, 49, 52-55, and 61-62, and has amended the claims to recite clear differences from one another:
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Additionally, the compounds of the claims of the ‘318 application differ from those of instant claims 58-60 and 63 for the same reasons as above. The amendments to the instant claims overcome the rejections, and thus the rejection is withdrawn.
Claims 1-5, 7, 12-20, 22-27, 29-43, 45-47, 50-55, and 59 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,054,478 (herein after the ‘478 patent) in view of Propellon Therapeutics (U.S. Patent App. Pub. US 2019/0119264, cited in the IDS of 11/26/2024, herein after “Propellon”). In response, Applicant has cancelled claims 2-5, 7, 12-20, 22-27, 32, 34-43, 45-47, and 50-55 and has amended instant claim 1 to solely recite Formula (I) where X1 and X3 are each CR9, wherein R9 is hydrogen, X2 is N, R7 is trifluoromethyl, and R8 is chloro. Stated differently, Applicant has amended the instant claims to require that the right-handed aryl be a 2-chloro-4-(trifluoromethyl)pyridine, which overcomes the rejection. Thus, the rejection is withdrawn.
Though the rejections of the Final dated 4/3/2025 have been overcome and withdrawn, a new rejection necessitated by the addition of a claim remains and is herein the subject of this Office Action.
NEW REJECTIONS
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.
Claim 63 is 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.
Claim 63 recites compounds with an amide bound to the triazole, whereas Formula I of claim 1 solely allows for a carbonyl in this position. Stated differently, Formula I solely allows for Y to be -C(O)- but the compounds of claim 63 recite -C(O)NH- as Y. Because claim 63 is dependent on claim 1, a lack of antecedent basis exists. Appropriate correction is required.
Allowable Subject Matter
Claims 1, 28-31, 33, and 58-60 are allowed.
REASONS FOR ALLOWANCE
The following is an Examiner’s statement of reasons for allowance:
Close prior art identified during the search is You (US 2021/0139466 A1, cited in the IDS of 11/26/2024). You is drawn to phenyl triazole MLL1-WDR5 protein-protein interaction inhibitors (abstract), and specifically teaches Example 4 (page 5):
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Which partially maps to instant Formula (I):
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when R6 is C1 alkyl, R4 and R5 are H, n is 1, R2 and R3 are H, Y is -C(O), and R1 is -NR15R16, where R15 and R16 are bonded to form a morpholine ring. Example 4 of You differs from compounds of the instant claims because the instant claims require L to be –(CH2)m, where m is 1-6, and require the right-handed aromatic ring to be a 2-chloro-4-(trifluoromethyl)pyridine. Example 4 taught by You was characterized by 1H NMR in DMSO-d6, indicating a pharmaceutical composition, and was furthermore subjected to biological testing (pg 11, para [0054] and pg 9, table 3).
Additionally, You teaches Example 7:
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Which solely differs from the compound of claim 58 by the right-handed aromatic ring:
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And differs from the compounds of claims 59 and 60 by the different right-handed aromatic ring and the lack of methyl groups on the piperazine:
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There is no teaching, suggestion, or motivation in You, alone or in combination with the prior art, to modify the teachings of you to arrive at the instant claims.
Additional close prior art identified is Propellon Therapeutics (U.S. Patent App. Pub. US 2019/0119264, cited in the IDS of 11/26/2024, herein after “Propellon”) which is drawn to inhibitors of MLL1-WDR5 protein-protein interactions and specifically teaches the following compound (page 119):
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Which contains the same methyl-piperazine-phenyl carboxamide moiety attached to a 2-chloro-4-(trifluoromethyl)pyridine as the instant Formula (I) and the compound of claim 58. The compound of Propellon differs from those of the instant claims because it contains a fluoro-phenyl-methylene-morpholine piece instead of a triazole with the amide-alkyl-morpholine chain. However, the above compound of Propellon is taught as an intermediate en route to final compounds and was not tested as an inhibitor of MLL1-WDR5 protein-protein interactions. Thus, the motivation for an artisan to choose the 2-chloro-4-(trifluoromethyl)pyridine is not present in Propellon.
Any comments considered necessary by Applicant must be submitted no later than the payment of the issue fee, and to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance”.
Conclusion
Claims 1, 28-31, 33, and 58-60 are allowed. Claim 63 is rejected.
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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