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 9, 15, 18, 20-21, 25-40, and 42-44 are cancelled.
Claims 1-8, 10-14, 16, 17, 19, 22-24, and 41 are pending.
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 12-14 and 41 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 pre-AIA the applicant regards as the invention.
Claims 12 and 41 recite parenthetical recitations, which makes the claims indefinite because it is unclear if the limitations within the parenthetical recitations are part of the claimed invention.
Claims 13 and 14 are included in the rejection because they do not correct for the defect of the claim from which it depends.
Appropriate correction is required.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-8, 10-14, 16, 17, 19, 22-24, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Strodiot et al. (US20210128474A1) hereinafter Strodiot.
Regarding claims 1-8, 10-14, 16, 17, 19, 22-24, and 41, Strodiot is drawn to methods for manufacturing a non-viral delivery system comprising a liposome encapsulating an RNA (abstract and claims 84-103).
Strodiot discloses mixing in the device a first solution comprising a solvent and a cationic lipid; and a second solution comprising water and the RNA; and removing the solvent. In some embodiments, methods of manufacturing a non-viral delivery system comprising a liposome encapsulating an RNA using a microfluidic device comprise the steps of: mixing in the device a first solution comprising a solvent, a cationic lipid, DSPC, a sterol, and a PEGylated lipid selected from PEG-PE and PEG-DMG; and a second solution comprising water and the RNA; and removing the solvent [0006].
Strodiot discloses the methods utilize a stock solution comprising a solvent and 1-10 mg/mL lipid. In some embodiments, the solvent comprises ethanol [0007].
Strodiot discloses liposomes within which polypeptide-encoding RNA is encapsulated. Thus the RNA is (as in a natural virus) separated from any external medium. Encapsulation within the liposome has been found to protect RNA from RNase digestion. The liposomes can include some external RNA (e.g. on their surface), but at least half of the RNA (such as at least 75%, at least 90%, and ideally all of it) is encapsulated in the liposome's core. Encapsulation within liposomes is distinct from, for instance, the RNA complexes where RNA is mixed with pre-formed liposomes [0023].
Strodiot discloses where a liposome herein is formed from a mixture of lipids, it is preferred that the proportion of those lipids which have a pKa within the desired range should be between 20-80% of the total amount of lipids e.g. between 30-70%, or between 40-60%. The remainder can be made of e.g. cholesterol (e.g. 35-55% cholesterol); and/or DMG (optionally PEGylated) or DMG PE; and/or DSPC. Such mixtures are used below. These % values are mole percentages [0026].
Strodiot discloses the biological activity of RNA encapsulated in liposomes comprising certain ionizable cationic lipids is several-fold higher than the same RNA encapsulated in liposomes comprising other ionizable cationic lipids. Thus, the selection of ionizable cationic lipid is an important parameter for generating RNA encapsulated liposomes having satisfactory biological activity. The activity of RNA encapsulated in liposomes can be measured by determining antigen expression in vitro using high content imaging as described in detail elsewhere herein [0030].
Strodiot discloses the liposomes will typically further comprise helper lipids. Useful helper lipids include zwitterionic lipids, such as DPPC, DOPC, DSPC, PEG-DMG (PEG-conjugated 1,2-Dimyristoyl-sn-glycerol, methoxypolyethylene Glycol) [0222].
Strodiot discloses the methods herein utilize lipids comprising (i) an ionizable cationic lipid having a pKa in the range of 5.0-7.6, (ii) DSPC, (iii) a sterol, and (iv) a PEGylated lipid. In some embodiments, the lipids comprise (i) a cationic lipid having Formula I, (ii) DSPC, (ii) a sterol, and (iv) a PEGylated lipid selected from PEG-PE and PEG-DMG. In some embodiments, the lipids consist essentially of (i) an ionizable cationic lipid wherein the cationic lipid comprises at least one hindered ester group; at least one carbonate group; or at least one aromatic group in the core, (ii) DSPC, (iii) a sterol, and (iv) a PEG selected from PEG-PE and PEG-DMG. In some embodiments, the sterol is cholesterol. In some embodiments, the lipids comprise a cationic lipid having Formula I, DSPC, cholesterol, and PEG-DMG. In some embodiments, the lipids comprise a cationic lipid selected from the group consisting of: DSPC, cholesterol, and PEG-DMG [0223].
Strodiot discloses pharmaceutical compositions of the invention may include the liposomes in a buffer e.g. a phosphate buffer, a Tris buffer, a borate buffer, a succinate buffer, a histidine buffer, or a citrate buffer [0294].
Strodiot does not explicitly disclose each of the components of the composition together as claimed in a single embodiment for an anticipation rejection.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Strodiot, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Strodiot discloses all the required ingredients and Strodiot discloses “a synergistic combination of environmental friendly surfactants able to reduce the water consumption and thus the environmental impact during the rinsing of cosmetic products, mainly hair dyes” (page 1). 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.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615