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 21-34 are pending in the application.
This action is in response to applicants' amendment dated June 11, 2026.
Response to Amendment
Applicant's arguments filed June 11, 2026 have been fully considered with the following effect:
With regards to the 35 U.S.C. 102(a)(1), anticipation rejection, labeled paragraph 1) in the last office action, the applicant’s arguments have been fully considered but are not found persuasive. The applicants’ stated that the pending claims relate to pharmaceutical compositions comprising the crystalline forms and processes for making the crystalline forms. Applicant further notes that the Office has previously acknowledged the patentability of the crystalline forms themselves in the parent application, which is now US Patent 11,999,750. Moreover, the Office acknowledges that Estrada does not disclose the particular crystalline forms, that is, any of Form A or Form B of (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido[3,2-b][1,4loxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide recited in the pharmaceutical compositions and processes of the pending claims. As stated in the last office action the crystalline Form A or Form B of (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido[3,2-b][1,4loxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide of claims 21 and 25, respectively would lose its claimed crystalline form upon being combined with any/all excipients and/or carriers. Claim 34 is directed to a pharmaceutical composition prepared by the process of claim 28. Crystalline Form refers to a solid state of matter where the atoms, ions, or molecules are arranged in a highly ordered, repeating, three-dimensional pattern known as a crystal lattice. Each crystalline form possesses a specific crystal lattice as shown by the six different crystalline forms described in the applicant’s specification and the XRPD, DSC, TGA of Forms A, B, C, D, E and F allowed in the parent application, i.e. U.S. Patent No. 11,999,750. However, once the Crystalline Forms are mixed with a pharmaceutically acceptable excipient, they no longer possess the specific crystal lattice. Any pharmaceutical composition comprising a crystalline form must maintain the crystalline structure.
The Applicants’ specification teaches that a “pharmaceutical composition, said crystalline Form A is at least 90 percent by weight of all forms”. Thus, the applicants’ own specification teaches that the “pharmaceutical composition” contains more than just Form A, Form B, etc. but a mixture of all Forms (See page 28). Polymorphs are distinguishable by various analytical techniques, especially X-ray powder diffraction patterns. With regards to the compositions the Carnegie Mellon Department of Physics teaches that the common industry practice when formulating a new drug to manufacture in dosage form is to rely on formulations (composition of inert additives) that worked with other drugs in the past. When this procedure fails (as is often the case) the formulation is changed by trial-and-error. The challenge is exacerbated by the fact that the formulation must achieve numerous, possibly competing objectives, such as control of chemical stability, disintegration and dissolution rates, polymorphism, crystal habit, and dosage uniformity. Because these systems have such complex compositions, and interactions between two or more formulation components often lead to unexpected consequences for one or more of the design objectives; there are few reliable, rational formulation design rules. Some formulations preserve the correct polymorph, others do not, and the reasons are usually not understood. This is a severe barrier in the pharmaceutical industry. Our aim is to develop new tools to give fundamental insight into identifying and controlling polymorphism in industrial processes through a molecular-level understanding. The applicants are not specifically claiming solid pharmaceutical compositions, but a composition comprising (S)-5-benzyl-N-(5-methyl-4-oxo-2,3,4,5-tetrahydropyrido [3,2-b][1,4loxazepin-3-yl)-4H-1,2,4-triazole-3-carboxamide.
Claim(s) 21-27 and 34 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Estrada et al., WO 2017/136727 (U.S. equivalent) U.S. Patent No. 9,896,458, for reasons of record and stated above.
Allowable Subject Matter
Claims 28-33 are allowed. None of the prior art of record nor a search in the pertinent art area teaches the process of preparing crystalline Form B as claimed herein.
Conclusion
THIS ACTION IS MADE FINAL. 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 BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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