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 .
Election/Restriction
Inventor’s election, without traverse, of the claims of Group I (claims 1, 2, 5, 7, 9-11, 14, 15, 18, 19, 26 and 27) and the species combination of sodium deoxycholate combined with Au(III) ions as the Group and species, respectively, elected to begin prosecution is acknowledged. The election/restriction is hereby made FINAL.
Markush Search
All elected claims have been examined with respect to formal matters.
The elected combination has been searched and is deemed free of the prior art. The search was, therefore, expanded as called for under Markush examination practice to include a single additional combination. That combination is (i) abiraterone acetate (a salt of a compound having a steroid core structure) and (ii) an acid with is citric acid.
All claimed but as yet unexamined subject matter which does not read on the above combination is hereby withdrawn from consideration, for purposes of this Office Action, as being drawn to non-elected subject matter. This subject matte will be rejoined as appropriate as the Markush examination progresses.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 9, 18, 26 and 27, in so far as they read on the combination above, are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 10,045,998 B2.
The reference teaches a solid, cocrystalline combination of abiraterone acetate with acids, such as citric acid, utilized as a pharmaceutical preparation (abstract; column 4, line 47). The solid, cocrystalline combinations are obtained as fine powders with a median size between 1-50 µm and preferably between 1-10 µm (column 6, line 65). Convention pharmaceutical carriers may be incorporated in the pharmaceutical formulations and are explicitly taught (column 7, line 29).
Claim 26 is included in this rejection because its limitation (that the particle is essentially free of transition metal nanoparticles) is intrinsic to the prior art solid, cocrystalline combination.
Allowable Subject Matter
The elected combination being free of the prior art, any claim, or portion of a claim, drawn exclusively to this elected combination constitutes allowable subject matter. That being the case, claims 2, 5 and 14 are objected to because they are drawn to both allowable subject matter (the elected combination), as well as subject matter which has not yet been completely searched.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 6/19/2026
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