DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 41-57 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Poole in view of Besman and Baheti. The .instant invention is drawn to a lyophilized pharmaceutical composition comprising melphalan flufenamide and trehalose. Poole teaches a freeze-dried melphalan hydrochloride as a two- component composition (see page 2 line 35). Component a) is melphalan hydrochloride which may be prepared using freeze drying procedures well known to those skilled in the art of pharmaceutical formulation (p2 l48). Besman teaches the use of well-known compounds fur use as reconstitution enhancers to lyophilized compositions of hydrophobic anticancer compounds (page 2). This is to be done with compounds that are hydrophobic and insoluble or substantially insoluble in water (pages 2 and 3). Besman teaches a reconstitution enhancer that is preferred enhancers are disaccharides such as trehalose (page 4). Baheti teaches trehalose as common excipients and bulking agents in lyophilized compositions (page 46). It would have been obvious to one of ordinary skill in the art at the time of the invention to make a lyophilized formulation of melphalan flufenamide or its derivatives as a HCl salt with trehalan and in a glucose solution. Poole teaches the lyophilization of melphalan flufanamide with other agents and Besman and Baheti teach why trehalan and glucose should be mixed in with the anti-cancer agent for faster solvation in a body. The use of glucose or any other reagent in the claimed invention would have been obvious because glucose is an art-recognized result-effective variable that is routinely determined and optimized in the medicinal arts.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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/D MARGARET M SEAMAN/
Primary Examiner, Art Unit 1625
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