DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
Claim Rejections – 35 U.S.C. 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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mecozzi et al. (US20210361573A1).
Regarding claims 1-20, Mecozzi is drawn to an ionic liquid composition comprising an at least partially hydrophobic ionic liquid, wherein the at least partially hydrophobic ionic liquid comprises a di cation comprising two monocationic groups linked by a bridging group wherein the bridging group provides an at least partially hydrophobic character. The composition may also include a hydrophilic ionic liquid. The hydrophobic ionic liquid may include a quaternary ammonium group which may be substituted or unsubstituted, saturated or unsaturated, linear, branched, cyclic or aromatic and the bridging group is a unsubstituted or substituted C3-C10 alkylene or C3-C10 alkoxy alkyl and methods to deliver a therapeutic agent by delivering a nanoemulsion and methods to make a nanoemulsion (abstract and claims 1-32).
Mecozzi discloses the inventive nanoemulsion comprises a therapeutic agent that is amphotericin B and said nanoemulsion provides reduced toxicity effects upon administration to a mammalian subject as compared to an emulsion in the absence of the ionic liquid composition [0076]. Mecozzi discloses the therapeutic agent in the nanoemulsion is amphotericin B and said amphotericin B has a concentration of between 0.05 mg/mL to 3 mg/mL relative to the hydrophobic liquid in said emulsion [0072].
Mecozzi discloses the absorption spectrum of Amphotericin B in an ionic liquid mixture and nanoemulsion indicates excellent monomerization. Hemolytic activity of the Amphotericin B in the ionic liquid nanoemulsion was negligible while maintaining antifungal activity against Candida albicans [0224].
Mecozzi discloses the hydrophobic drug is a polyene antifungal agent. In another preferred embodiment, the hydrophobic drug comprises, consists essentially of, or consists of amphotericin B [0276].
Mecozzi discloses the composition formulated into a variety of suitable formulations and administered orally, in aerosol form, parenterally, subcutaneously, intravenously, intramuscularly, intraperitoneally, interperitoneally, rectally, topically and vaginally [0280].
Mecozzi does not explicitly disclose the method as claimed together in one single embodiment for an anticipation rejection.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the teachings of Mecozzi to arrive at the instant invention, with the motivation that Mecozzi discloses each of the required components and amounts, and for the same purpose of to an ionic liquid composition comprising a therapeutic agent that is amphotericin B and said nanoemulsion provides reduced toxicity effects upon administration to a mammalian subject as compared to an emulsion in the absence of the ionic liquid composition (abstract; [0076]).
Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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