entoDETAILED 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 .
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, 6, 10, 15, 19, 23, 26, 32 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (ACS Nano, Author manuscript, 2017, pp. 2702-2715, disclosed by applicant) in view of Jin et al. (Journal of Visualized Experiments, Vol. 132, pp. 5-7, disclosed by applicant).
Liu et al. disclose a method of preparing a purified liposomal compositions comprising irinotecan, which meets the limitation of a topoisomerase inhibitor of instant claim 26 (p. 2711). Liu et al. disclose after probe sonification, the articles were purified by centrifugation and washing and resuspended; wherein the liposomal carriers that use a protonating agent for drug loading, such as ammonium sulfate (p. 2703). Liu et al. disclose the liposomes comprise a lipid bilayer which uses a proton gradient for high-dose irinotecan loading across a coated lipid bilayer; an internal medium where the vesicle was used for loading of irinotecan by a trapping agent, triethylammonium sucrose octasulfate; and a therapeutic agent encapsulated in the internal medium of the liposomes (p. 2704). Liu et al. disclose the therapeutic agent has low water solubility, wherein the entrapment of the protonating agent that converts amphipathic irinotecan, capable of diffusing across the lipid bilayer, into a hydrophilic derivative that is retained in the pores and can be protonated to a protonated form (.p. 2704). Liu et al. disclose the method comprises providing crude liposomal composition and purifying the crude liposomal composition with an aqueous solution. The washed particles where resuspended in water, saline or dextrose. Liu et al. discloses the lipid bilayer comprises a first lipid and a first sterol composition of DSPC/cholesterol/DSPE-PEG2000; the internal medium comprises a first loading aid using TEASOS (p. 2704). Liu et al. disclose the lipid 1,2-distearoyl-sm-glycero-3-phosphoethanolamine-poly(ethylene glycol) such as DSPE-PEG2000 (p. 2704)
Liu et al. differs from the instant claims insofar as they do not disclose an acidified aqueous solution or the first lipid is DSG-PEG2000.
Jin teaches liposomes can be purified using acidified aqueous solutions. The liposomes compartments bounded by bilayer membranes comprised of amphophilic lipids have found use in numerous biomedical application as delivery vehicles for pharmaceuticals, model of cell membranes, and for the development of synthetic cells.
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to purify the liposomal composition of Liu by using the acidified aqueous solution disclosed by Jin by routine experimentation motivated by the desire to find the most effective purification method. It would have been obvious to one of ordinary skill in the art to apply DSG-PEG2000 to the liposomal composition disclosed by Liu by routine experimentation , in order to find the most effective composition.
Claim(s) 1, 12, 14, 24, 27, 28, 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (ACS Nano, Author manuscript, 2017, pp. 2702-2715) in view of Jin et al. (Journal of Visualized Experiments, Vol. 132, pp. 5-7) and further in view of Drummond (WO2017123616A1, disclosed by applicant).
Liu in view of Jin is discussed above and differs from the instant claims insofar as they do not teach the solvent DMSO or additional therapeutic agents.
Drummond discloses liposome preparations comprising powders in aqueous methanesulfonic acid at a concentration of 1M ([00105]). Drummond discloses the Bcl inhibitor Comparator B, which meet the limitation of the Bcl inhibitor of instant claim 40 ([0053]). Drummond discloses the claimed compound and one of ordinary skill would have expected the compound to comprise the claimed properties of cLogP of greater than about 2 and the protonated form has a pKa of greater than about 2. Drummond discloses the Comparator B solution in DMSO was loaded into the liposomes of DSPC, cholesterol and PEG(2000)DSG ([00105]).
It is prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art to have used the components of Drummond in the liposomes of Liu in view of Jin since they are known for liposomal formulations.
Conclusion
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/NANNETTE HOLLOMAN/ Primary Examiner, Art Unit 1612