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
Acknowledgement is made to Applicant’s response filed 10/20/2025.
Claims 1-10, and 12-17 are pending.
Election was made without traverse in the reply filed on 10/20/2025.
Claims 1-10, and 12-17 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
low phase transition substance: cannabidiol;
oil: medium chain triglycerides;
PEGylated lipid: PEG-PE;
surfactant: alpha lecithin;
co-solvent: ethanol;
active ingredient: netupitant.
Upon further search and examination the species election over oil is broadened to include coconut oil, olive oil, hemp seed oil, soyabean oil, and vitamin E. The species election over surfactant is broadened to include egg lecithin, polysorbate 20, polysorbate 60, polysorbate 80, poloxamer 182, poloxamer 407, poloxamine 908, and poloxamer-188. As well as the species election over active ingredient is broadened to include palonosetron, atorvastatin, gabapentin, naproxen, paclitaxel, and duloxetine.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/07/2023 is being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
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.
Claim(s) 1-10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (US 20180296493 A1; as submitted on IDS of 06/07/2023) and Liversidge et al (US 6270806 B1).
Kaufman in examples discloses cannabinoid phospholipid nanoparticle carrier (a nanolipid carrier system per instant claim) composition comprising, 25-75% Cannabinoids, phospholipids, oil (medium chain triglycerides, hemp seed oil), surfactants (such as egg lecithin (LIPOID E 80 S), polysorbates such as Polysorbate 80 and Polysorbate 20), solvents, and carrier fluids and 0-10% buffers (Paragraphs [0237]- [0239]). Kaufman teaches cholesterol (a low phase transition lipid) ([0176]). Kaufman discloses solvents such as ethanol ([0194]). Kaufman teaches the essential phospholipid fraction includes phosphatidylethanolamine, phosphatidylinositol and other lipids (see entire document, for instance, [0037]). Kaufman teaches the weight concentration encapsulated in the nanosphere phospholipid nanoparticle composition for (cannabidiol) CBD is 19.9 % and the nanoparticle increases the bioavailability of the cannabinoid 2 to 8 fold compared to bioavailability without nanoparticle encapsulation (see entire document, for instance, Example 5, claim 11, [0256]). Kaufman discloses, nanoparticle structures have a particle size distribution from 50 to 150 nm and readily pass across cell membranes (see entire document, for instance, [0035], claim 14). Thus, it can be concluded the multi-fold increase in bioavailability in Kaufman is necessarily resulted due to the multi-fold rise in permeability. Kaufman discloses phospholipid nanoparticle carrier compositions of cannabis and methods of delivery where the nanoparticle carrier composition or constituents that deliver standardized dosages of cannabinoids suited for oral, intraoral, intranasal and/or transdermal administration ([0098]). Kaufman teaches the essential phospholipid fraction includes phosphatidylethanolamine, phosphatidylinositol and other lipids (see entire document, for instance, [0037]). However, it a does not expressly disclose including a PEGylated lipid such as LIPOID PE or Polyethylene glycol monostearate. Liversidge et al remedy this deficiency.
Liversidge disclose nanoparticulate formulations of a drug having at least one polyethylene glycol (PEG)-derivatized phospholipid (column 1, lines 6-8). Liversidge teaches a lipid is an inclusive term for fats and fat-derived materials (column 1, line 39). Exemplary lipids include phospholipids such as phosphatidylethanolamine (column 1 line 49). PEG is particularly useful because of its ease of preparation, relatively low cost, controllability of the molecular weight, and the ability to link to lipid by various methods. (column 2 lines 56-59). PEG-lipids are highly superior over conventional lipids as they exhibit: (1) prolonged blood residence times, (2) a decreased rate and extent of uptake into the MPS with reduced chance of adverse effects to this important host defense system, (3) dose-independent pharmacokinetics in animals and humans, and (4) the ability to cross in vivo biological barriers (column 3, lines 43-49). Liversidge disclose studies of doxorubicin and epirubicin encapsulated in PEG-phospholipids for decreasing tumor size and growth showed that the encapsulated drugs had a much longer half-life than free drug and are cleared much more slowly from the circulation (for PEG-phospholipid encapsulated doxorubicin, the distribution half-life was about 42 hours, in contrast to the distribution half-life of about 5 minutes for free doxorubicin) (column 3, lines 58-65). Liversidge teaches PEG-lipids may enhance cytotoxic cell delivery is by protecting drugs that rapidly degrade from contact with plasma for prolonged periods (column 4, lines 28-32). Liversidge teaches because of the stability of PEG-lipids, drug/PEG-lipid nanoparticulate compositions afford enhanced blood pool residence times, decreased toxicity, and increased stability of an administered drug (column 4, lines 59-63).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Kaufman and Liversidge et al. It would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each component from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
Claim(s) 1-10 and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (US 20180296493 A1; as submitted on IDS of 06/07/2023) and Liversidge et al (US 6270806 B1) as applied to claims 1-10 and 12-14 above, and further in view of Podaralla et al (US 20180344644 A1).
The teachings of Kaufman and Liversidge et al have been set forth above. Kaufman discloses phospholipid nanoparticle carrier compositions of cannabis and methods of delivery where the nanoparticle carrier composition or constituents that deliver dosages of cannabinoids suited for oral, intraoral, intranasal and/or transdermal administration ([0098]). Liversidge teaches PEG-lipids may enhance cytotoxic cell delivery is by protecting drugs that rapidly degrade from contact with plasma for prolonged periods (column 4, lines 28-32). However, they do not expressly disclose including one or more active ingredients are selected from the group consisting of netupitant, palonosetron, atorvastatin, gabapentin, naproxen, abiraterone, cabazitaxel, paclitaxel, duloxetine and many other drugs and there combinations thereof.
Podaralla et al remedy this deficiency. Podaralla discloses improved stable liposomal formulations and method of preparation thereof (abstract). The liposomal formulations include liposomes containing a phosphatidylcholine lipid, a sterol, a PEG-lipid, and a taxane, wherein the taxane is docetaxel or a derivative thereof (abstract). The liposomal formulations have improved stability and extended shelf-life (abstract). Podaralla teaches cholesterol (see entire document, for instance, claim 8). Podaralla discloses paclitaxel (see entire document, for instance, claim 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to formulate a combination of cannabidiol with paclitaxel and many other active ingredients and combinations thereof. One would have been motivated to do so since Kaufman and Liversidge teaches PEG-lipids may enhance cell delivery is by protecting drugs that rapidly degrade from contact with plasma for prolonged periods.
Conclusion
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611