CLAIMS 1-20 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s Preliminary Amendment filed December 07, 2022 and Information Disclosure Statement filed March 01, 2022 have been received and entered into the application. Accordingly, the application papers have been amended as directed. Also, as reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered.
Allowable Subject Matter Indicated
Claims 1-3, 5, 6, 8 and 11-18 are deemed allowable.
Claim 1 is representative of the claimed subject matter and reads:
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The prior art closes to the claimed subject matter is: Alfonsi R. et al., "Characterization of mitotane (o,p '-DDD) - cyclodextrin inclusion complexes: Phase-solubility method and NMR," Annales Pharmaceutiques Francaises, Vol. 71, Issue 3, pp. 186-192 (May, 2013) (Year: 2013), (hereinafter “Alfonsi”, cited and copy provided by the Examiner).
Alfonsi teaches a mitotane and cyclodextrin complex which was studied using both phase-solubility methods and NMR experiments because unlike mitotane, the complex is very soluble in water which lends itself to an improved bioavailability, (see the abstract). The complexes were diluted with water, (pg. 3, line 3). Other compositions taught include a simple freeze-dried mitotane-cyclodextrin complex, (pg. 3, under the heading “Lyophilization of the complexes”. Nowhere, however, does the reference teach an emulsion, i.e., a mixture of two or more liquids that are normally immiscible having an oily phase enriched with mitotane and cyclodextrin which emulsion is a dry emulsion.
For the above reasons, as well as that the claims are enabled and definite, the Examiner finds the above claims to be allowable.
Claim Rejection - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 7, 9, 10, 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In particular, in claim 4, “the cyclodextrin derivatives” finds no antecedent basis. In claim 7, it is unclear whether the parenthetical phrase represents a controlling limitation in the expression “granules (pellets),”. In claim 9, the term “use” is nebulous and fails to particularly point out any steps to be taken in order to accomplish the claimed objective of treatment.
Also, in claim 10, “the aqueous phase” has no antecedent basis. Also, the claim reads “to obtain an O/W primary emulsion then a dry emulsion based on mitotane, drying…” which makes it unclear how a dry emulsion is formed before the recitation of a step of drying. Finally, “the grains” finds no antecedent basis.
Claims 19-20 depend from claim 10 and thus are properly rejected as being indefinite.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 November 27, 2025