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 .
Claims 1, 2, 10-13, 15, 18, 21, and 24-27 have undergone amendments. Thus, Claims 1-15, 18, and 21-29, submitted on 25 June 2025, represent all claims currently under consideration.
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.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 25 June 2025, is acknowledged and has been considered.
Response to Amendment
The objections to Claims 1, 10, 11, 12 and 13 are withdrawn. Applicant has amended all representations of oxygen with “O”.
The objection to Claim 21 is withdrawn. Applicant has amended Claim 21 to add a space in between the terms “other” and “tauopathies”.
The 35 U.S.C. § 112(a) rejection of Claims 18 and 21-26 for not being enabling for the prophylaxis of diseases is withdrawn. Applicant has amended the claims to remove references to methods of prevention of disease.
The 35 U.S.C. § 112(b) rejection of Claim 1 as indefinite for omitting the point of attachment to the nitrogen atom is withdrawn. Applicant has amended Claim 1 to include the symbol which indicates the point of attachment to the nitrogen atom.
The 35 U.S.C. § 112(b) rejection of Claims 1, 10, and 12 for indefiniteness for reciting the term “Ci_2” is withdrawn. Applicant has amended Claims 1, 10, and 12 to replace the term “Ci_2” with “C1-2”.
The 35 U.S.C. § 103 rejection of Claims 1-15 and 25-29 over Nordvall (WO 2019/162742) in view of PubChem CID 3157485 is withdrawn. WO 2019/162742 names two inventors, Gunnar Nordvall and Pontus Forsell, both of which are the named inventors on the examined application, and does not name another inventor other than the inventors of the examined application. WO 2019/162742 was published on 29 August 2019, which is not prior to the effective filing date of the examined application of 29 August 2019. As this does not qualify as prior art under 35 U.S.C. § 102, the rejection is withdrawn.
The 35 U.S.C. § 103 rejection of Claims 1-8, 14-15, and 25-29 under 35 U.S.C. § 103 over Nordvall (WO 2018/115891) in view of Geldenhuys (Therapeutic Delivery, 2015, 6(7), 961-971) is withdrawn. Applicant claims that there is no teaching, suggestion or motivation in the prior art which would lead one of ordinary skill in the art to modify the art in the manner required to arrive at the instant claims. The Examiner agrees. Nordvall does not provide any teaching nor suggestion to improve the BBB penetration of the compounds, and teaches away from improving BBB penetration as these compounds act on the central nervous system. Therefore, one of ordinary skill in the art would not be motivated to modify these compounds to enhance BBB penetration as they are already capable of crossing the BBB. Further, the U group of the compounds of Nordvall is a mandatory feature, and the artisan would assume this is essential for activity against TrkA and TrkB receptors. Therefore, the artisan would not have a reasonable expectation of success to modify the compounds by removing these groups.
Terminal Disclaimer
The terminal disclaimer filed on 25 June 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11,840,524 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer filed on 25 June 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 12,209,071 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Double Patenting- NEW GROUNDS OF REJECTION
Claims 1-15, 18, and 21-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 10, 12, 19, 20, 22, 25, 26 and 39 of copending Application No. 18/974,921 (Amended Claims of 19 March 2025) (‘921).
Co-pending application is a continuation of US Patent 12,209,071, which is a divisional of US Patent 11,353,232, which all claim priority to documents which have earlier filing dates than the examined application.
Claim 1 of ‘921 is directed to a compound of Formula (I)
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wherein R1 represents phenyl substituted by one or more G1 groups; or a 5- to 9- membered heteroaryl group optionally substituted by one or more G2 groups; G1 represents halo, phenyl, phenoxy, cyano, a 4- to 7- membered heterocyclic ring, a C1-C4 alkyl group or C1-C4 alkoxy group which may be optionally substituted by one or more fluoro atoms; G2 represents halo, phenyl, phenoxy, a 4- to 7- membered heterocyclic ring, a C1-C4 alkyl group or C1-C4 alkoxy group which are optionally substituted by one or more fluoro atoms; n represents 0, 1, or 2; R2 represents a C1-C6 alkyl group or a C1-C6 alkoxy group which may be optionally substituted by one or more fluoro, =O, hydroxy, alkoxy, or are optionally substituted by a 4- to 7- membered heterocyclic ring or a phenyl group; Q represents -CH-; X represents -CH2-, -O-, -S-, or -NH-; m represents 0; p represents 0; or a pharmaceutically acceptable salt thereof. Claim 6 claims the compound of Claim 1 wherein R1 represents phenyl optionally substituted with a fluoro, chloro, methyl, methoxy, trifluoromethyl, or trifluoromethoxy substituted in the 3- or 4- position relative to the attachment point of the benzene ring. Claim 9 claims the compound of claim 1 wherein n is 1. Claim 10 claims the compound of Claim 9 wherein R2 represents a linear or branched C1-C4 alkyl or C1-C5 alkoxy located at the 3-position relative to the triazine ring. Claim 19 claims a pharmaceutical composition of a compound of Claim 1 and a pharmaceutically acceptable excipient. Claim 20 claims a method of treatment of a disease characterized by impaired signaling of neurotrophins and/or other trophic factors, which comprises administering a compound of Claim 1. Claim 22 claims the method of claim 20, wherein the disease or disorder is selected from a group of diseases/disorders which encompasses those claimed in the examined application. Claim 25 claims a process for the preparation of a compound of Claim 1 comprising the step of reacting a compound of Formula II
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as defined in Claim 1 with ethoxycarbonyl isocyanate. Claim 26 claims specific compounds, several of which meet the limitations of Claim 1 of the examined application such as 1-(3-methoxy-4-phenoxyphenyl)-3-phenyl-1,3,5-triazinane-2,4,6-trione
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. Claim 39 claims the method of Claim 22 wherein the compound is 1-(3-methoxy-4-phenoxyphenyl)-3-phenyl-1,3,5-triazinane-2,4,6-trione.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-15, 18, and 21-29 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625