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/Restrictions
Applicant’s election without traverse of Group I (1, 2, 5, 9, 10) in the reply filed on 08/22/2025 is acknowledged.
Claims 11-15 and 18-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/22/2025.
Claim Rejections - 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 1, 2, 5, 9 and 10 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.
Claim 1 recited the limitation “a) preparing a mixture of olelyl phosphocholine, an anti-oxidant, a filler a granulation liquid and, optionally one or more further granulation excipients” in lines 3-4. What is a “filler a granulation liquid”? It is not quite clear if step a) requires a granulation liquid in view of the phrase “a filler a granulation liquid and optionally one or more further granulation excipients”. Are these a mixture of components required altogether as a mixture?
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.
Claims 1, 2, 5, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Herwig WO 2012069427 A1, in view of Pelipenko et al. US 20190029962 A1 and Eibl et al. US 5,290,769.
Herwig teaches a solid dosage form of oleyl phosphocholine (C18:1-PC), or OlPC, for oral administration. Further, the present invention relates to methods for the preparation of the present solid dosage forms and the use thereof as a medicament and especially a medicament for treatment of parasitic diseases, such as leishmaniasis, chagas and malaria, and cancer both in humans and animals. Specifically, the present invention relates to a solid dosage form comprising:6 to 25 weight % of the solid dosage form oleyl phosphocholine; 20 to 35 weight% of the solid dosage form lactose; 35 to 50 weight % of the solid dosage form cellulose; 5 to 20 weight% of the solid dosage form croscarmellose; 1 to 10 weight% of the solid dosage form hydroxypropylmethyl cellulose; and0.05 to 1 weight% of the solid dosage form of a lubricant. See Abstract. The claimed excipients such as filler, binder, and the like is found in pages 3-4. According to another aspect, the present invention relates to a method for the preparation of the present solid dosage forms, using the weight percentages presented above, comprising the steps of: a) adding to a dry mixture comprising one or more pharmaceutically acceptable diluents/ fillers, disintegrants and/or binders water comprising 6 to 25 weight% of the solid dosage form oleyl phosphocholine; b) drying and sieving the mixture obtained in step (a); c) adding one or more disintegrants and/or lubricants to the mixture obtained in step (b); d) mixing the mixture obtained in step (c); e) preparing an oral dosage form of the mixture of step (d). See pages 8-9. Wet granulation process is found in page 9 and Examples.
Herwig does not expressly teach antioxidant among the excipient present in the composition. However, the use of antioxidant in a wet granulation process is known in the art. See for example the teaching in Pelipenko, which teaches a wet granulation process comprising preparing a mixture of active agent, solvent and antioxidant, spray drying the mixture to obtain a dry granulation, and milling to obtain powder. See pages 4-6, Examples, and Claims. Paragraph 0077 discloses antioxidant including vitamin E, tocopherol, alpha-tocopherol and BHT.
Thus, it would have been prima facie obvious to one of ordinary skill in the art to, by routine experimentation include antioxidant in view of the teaching of Pelipenko with the expectation to obtain a stable OLPC composition similar to that of the present invention. This is because combining OLPC with an antioxidant is known in the art (see for example the teaching in Eibl et al. US 5,290,769, and this is because Pelipenko teaches a wet granulating process useful for active pharmaceutical active agents that exhibit challenging physical and/or physicochemical characteristics, e.g. being sensitive towards moisture, and because Herwig teaches the desirability for using a wet granulation process. Surprisingly, it has been found in the present invention that the use of a pharmaceutically acceptable excipient that has neutral or acidic properties in the process according to the present invention can result in granules or particles that exhibit an improved stability, e.g. less degradation products occur. Additionally, by applying the inventive process, the obtained granules and particles can exhibit an improved dissolution profile. Additionally, by applying the inventive method, it is even possible to use an aqueous granulation liquid, e.g. water or mixtures of water with organic solvents, or mixtures of organic solvents, for preparing the granules and/or particles and adsorbates. See Pelipenko at paragraph 0058.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615