DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
A Preliminary amendment was filed on 01/14/2025.
Terminal Disclaimer
A terminal disclaimer over US Patent No. 11,839,689 was approved on 11/07/2024.
A Track One Request was denied on 12/03/2024
Information Disclosure Statement
Information disclosure statements were filed on 02/31/2025, 03/05/2025, 03/19/2025, 05/12/2025, 06/03/2025, 06/19/2025, 06/24/2025, 07/16/2025, 08202025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
Claim(s) 1-2 is/are rejected under pre-AIA 35 U.S.C. 102(a)(2) as being anticipated by WO 2014/043208 (WO’208)
WO’208 discloses a solid dispersion of amorphous dispersion of amorphous enzalutamide in a cellulosic concentration enhancing polymer such as HPMCAS See process described on page 9; and claim 11, step a). The patent also comprises ionizable non-cellulosic polymers at [55]- [56] which are copolymers of methacrylate and acrylate. He claims are anticipated by WO’208.
Conclusion
No claims are allowed.
The declaration under 37 CFR 1.131(a) filed 10/13/2024 is noted. However, it is directed to derivation of an amorphous enzalutamide dispersion comprising HPMCAS which is not claimed in the instant application, and is therefore ineffective over the reference cited above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
