DETAILED 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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR2022/006174, filed on April 30, 2021.
Claim Status
Claims 1 - 9 are pending in the application.
Claim Objections
Claims 1, 4 - 6, and 9 are objected to because of the following informalities: grammatical and typographical errors which detract from the clarity of the claims. Claim 1 needs to include appropriate articles in the claim such as “a cationic compound” and “a salt” in line 2, “a drug”, “an effective” and “a nucleic” in line 4, “a polypeptide” and “a virus” in line 5, and “an amphiphilic” in line 6. Claim 4 needs to include appropriate articles in the claim such as “an aqueous”, and “a water” in line 2. Claim 5 needs to include appropriate articles in the claim such as “a pH adjusting” in line 2, “an inorganic”, and “a saccharide” “a surfactant”, and “a chelating” in line 3. Claim 6 needs to include appropriate articles in the claim such as “the drug” in line 1, “the effective”, “the nucleic”, “the polypeptide”, “the virus” in line 2, “the cationic” “the salt”, “the solvent”, “the additives” in line 4, and “the pH”, “the inorganic”, the saccharide”, “the surfactant”, and “the chelating agent” in line 5. Claim 9 needs to include appropriate articles in the claim such as “a solution”. Appropriate correction is required.
Claim Interpretation
Claims 2 and 9 are drawn to an intended use of the invention. The recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the intended use recited in claim 2, namely that the drug containing nanoparticles are for intracellular delivery of the drug, is not afforded patentable weight. Furthermore claim 9 recites “the cationic compound and salt of polylactic acid are used for the nanoparticle preparation in the form of a solution that is filtered one or more times”. Thus, the intended use and filtration of claim 9 are also not afforded patentable weight.
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 3 and 6 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.
In regard to claim 3, the recitation of “The kit for preparing drug-containing nanoparticles of Claim 1, wherein one or more selected from the group consisting of the first chamber and the second chamber further comprise additional solvent” lacks a clear subject and therefore it is unclear which element of the kit is intended to further comprise the solvent. Accordingly, the metes and bounds of the claim cannot be determined.
Claim 6 depends from claim 1, which recites a kit comprising a first chamber and a second chamber. However, claim 6 recites that the kit consists of a list of ingredients, cationic compound, salt of polylactic acid, solvent, and additives without reciting the chamber of claim 1 or specifying the relationship of the listed ingredients to the chambers. Therefore, it is unclear whether the chambers of claim 1 remain part of the claimed kit or whether claim 6 redefines the kit as consisting solely of the listed ingredients. Accordingly, the metes and bounds of claim 6 are unclear and the claim is indefinite. The Examiner suggests amending claim 6 to clarify the relationship between the recited ingredients and the chambers of claim 1 so that the scope of the claim is clearly defined.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Betbeder et al.(US-20200060981-A1, Feb 27. 2020) in view of Goepferich et al. (US-9579394-B2, Feb. 28, 2017) and NAM et al. (US-20180344638-A1, Dec. 6, 2018).
Betbeder et al. teaches cationic nanoparticles combined with viruses and a method of preparation (paragraph [0007]). Specifically, they disclose suitable nanoparticles including chitosan (paragraph [0021]) and cationic polylactic acid (PLA) (paragraph [0022) and teach that PLA nanoparticles can be coated with cationic compounds such as chitosan (paragraph [0025] and [0026]). Notably, Betbeder et al. is silent on the composition comprising an amphiphilic polymer. Furthermore, they disclose a preferred embodiment, where the cationic nanoparticle used according to the invention is selected from cationic polysaccharide nanoparticles, with a lipid core nanoparticle (paragraph [0026]). They further state the nanoparticle “solution may be an aqueous solution, a buffer
solution or a serum solution” (paragraph [0018]) as required by Applicant’s claim 4. Betbeder et al. also discloses a combination product is preferably obtained through adding the virus with the cationic nanoparticles (paragraph [0029]) and that the “invention further relates to a pharmaceutical composition comprising the combination product… and at least one pharmaceutically acceptable excipient” (paragraph [0041]). Specifically, Betbeder et al. teaches pH adjusting agents such as sodium hydroxide and acetic acid (paragraph [0057]) in addition to chitosan which is a saccharide (paragraph [0061]).
Betbeder et al. does not disclose (A) the two-chamber kit recited in claim 1 and 3, and (B) the salt of polylactic acid with relative amounts as recited in claims 1, 7 and 8.
With regard to limitation (A) Goepferich et al. teaches nanocomplexes of polyanion nucleic acid and cationic peptide (column 5, line 62). They also disclose that the “complexes of polyanion and peptide are preferably formed spontaneously when two solutions are mixed. For this purpose, polyanion and peptide are mixed together at a defined concentration and defined volume, each dissolved in a solvent, e.g. water. This can be done outside the human or animal organism or in situ, i.e., in the course of application, for example by injection, such as with a dual-chamber syringe” (column 6, lines 7-14). Furthermore, they suggest that it may be necessary to adjust physicochemical parameters, such as pH, ionic strength or osmotic pressure before or after mixing (column 6, lines 14-16). Since dual-chamber systems were known in the art at the time as a delivery format, it would have been obvious to provide the nanoparticle-virus system of Betbeder et al. in the known dual-chamber configuration of Goepferich et al.
With regard to limitation (B) NAM et al. teaches the formation of nanoparticles comprising a drug, a cationic compound, an amphiphilic block copolymer, and optionally a polylactic acid salt (paragraphs [0012] and [0013]). NAM et al. also teaches the function of the polylactic acid in the system as stabilizing to the micelle (paragraph [0058]). The sodium polylactic acid (PLANa) salt would be anionic therefore it would bind to the cationic complex more effectively and improve delivery efficiency to cells (paragraph [0058]). NAM et al. also teaches that the cationic compound may be present in an amount of 0.01-50 wt. % of the total composition specifically 0.1-10 wt. % (paragraph [0045]) and that the PLA salt may be present in an amount of 1-200 parts by weight, relative to 100 parts by weight of amphiphilic block polymer (paragraph [0060]). These disclosures overlap with the ranges for cationic compound and PLA in claims 7 and 8 of the instant application and demonstrate that the relative amounts of the compounds are adjustable formulation parameters.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, to modify the nanoparticle composition of Betbeder et al. to be provided in a dual-chamber system as taught by Goepferich et al. while incorporating the PLA salt taught by NAM et al. One of ordinary skill would have been motivated to modify Betbeder et al. in this way because they specifically disclosed a combination product is preferably obtained through adding the virus with the cationic nanoparticles (paragraph [0029]) and also described a pharmaceutical composition comprising the combination product (paragraph [0041]). Goepferich et al. taught complexes may be formed by mixing two solutions using their dual-chamber syringe while NAM et al. taught that PLA salts stabilize cationic nanoparticle complexes and improve delivery efficiency which would be obvious to use in a combination product to produce a pharmaceutical composition of Betbeder et al. Therefore modification of Betbeder et al. in view of Goepferich et al. and NAM et al. would have yielded a drug-containing nanoparticle delivery system having the features of Applicant’s claims 1-9.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH JAIPRASHAD whose telephone number is (571)272-1049. The examiner can normally be reached Monday-Friday 8AM-5PM.
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/RAJESH JAIPRASHAD/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691