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 .
Detailed Action
Upon further consideration and in view of Applicant’s arguments, the finality of the previous office action is withdrawn and new rejections are made herein.
Claim Objections:
The examiner suggests defining the abbreviations “DSC and DIN EN ISO 11357-2” used in the claims at least once.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cerdeira et al. (International Journal of Pharmaceutics, Vol. 443, 2013, pages 209-220).
Cerdeira et al. discloses for very slightly water-soluble or practically water-insoluble drug substances, nanosuspensions are of great interest, as they can be formulated with up to 40% drug content in either aqueous or mixed aqueous-organic solvents, require only small amounts of non-toxic excipients, and may preserve drug stability better than other formulations (Patravale et al., 2004), see Introduction, column 1, first paragraph. Cerdeira et al. is drawn to the formation of micronazole and itraconazole nanosuspensions, as of Cerdeira, page 209, title and abstract. Cerdeira teaches the following method, as of page 210, right column, starting at bottom paragraph and going onto page 211, relevant text reproduced below:
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HPC refers to hydroxypropyl cellulose, which is a polymer, and SDS refers to sodium dodecyl sulfate, which is an anionic surfactant. As to the required step of suspending a pharmaceutically active substance in an aqueous solution of a polymer, as best understood by the examiner, the above-reproduced text suspends active substance in water dissolving hydroxypropyl cellulose. Cerdeira teaches drying, as of the above-reproduced spray drying process. As to the one or more surfactant, the above-reproduced text from Cerdeira appears to teach dissolving sodium dodecyl sulfate in water prior to drying. As such, the skilled artisan would have been motivated to have contacted the active agent with sodium dodecyl sulfate prior to the drying step. Cerdeira teaches milling, as of page 209, third line in abstract. Cerdeira teaches spray drying, as of the above-reproduced text. Cerdeira teaches the melting temperature of Itraconazole to be 168degrees Celsius, see page 210, left column, paragraph 4. Nanogrinding of drug substance is taught under section 2.2 on page 210.
The reference does not teach the claimed temperatures and time span and also the glass temperature determination with DSC according to DIN EN ISO 11357-2, however, the reference does teach nano-dry-grinding and melting as discussed above. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have manipulated the temperatures based on the guidance provided by Cerdeira et al. regarding nano-dry grinding and come to the claimed invention.
Thus, the art teaches formulation and drying of nanosuspensions, nanogrinding and drying process with active ingredients that have less than 10g/l of solubility along with polymer and surfactant. This combination is not in a single embodiment. However, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results of making an amorphous solid dispersion comprising ingredient having low solubility, see MPEP 2143 part (I)(A).
Applicant’s arguments are moot in view of new rejections made above.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612