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 .
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.
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) 1-4, 6-11, 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albertsen et al., (Advanced Drug Delivery Reviews 2022) and Mizuta et al. (Nanoscale Advances 2022, cited in IDS).
Albertsen et al. teaches the role of lipid components in lipid nanoparticles for vaccines and gene therapy (Ti.).
The nanoparticles are designed to deliver nucleic acids to a patient insofar as they have been defined “as sub-micron particles containing ionizable cationic lipids in addition to other types of lipids and encapsulated nucleic acid cargo” (p. 2, left col., Introduction, 1st paragraph). “Preclinical studies have used LNP’s to deliver nucleic acids beyond siRNA and mRNA, such as antisense oligonucleotides (ASOs), microRNA, and DNA” (Id. 3rd paragraph), as per claims 6-10.
Albertsen et al. teaches an example of a typical lipid nanoparticle containing “ionizable lipid, a phospholipid, cholesterol, and PEG-lipid (about 50:10:38.5:1.5 mol%)” (p. 2, right column, 4th paragraph).
Here the prior art teaches a lipid nanoparticle comprising an ionized lipid within the claimed range of 35-70 mol%, i.e. 50 mol%; a phospholipid within the claimed range of 4-25 mol%, i.e. 10 mol%; a sterol (cholesterol) within the claimed range of 15-55 mol%, i.e. 38.5 mol%.
The 1.5 mol% PEG-lipid suffices as the complex lipid that inhibits particle aggregation, i.e., polyethylene glycol-lipid conjugate, as per claims 13-15.
In terms of particle size, Albertsen et al. teaches “a size of 100 nm” (see p. 13, Fig. 7), as per claim 16.
Routes of administration taught therein include “intramuscular (i.m.) injections” (p. 5, left col., 5th paragraph). Since the lipids are used in vaccines for treating disease (COVID-19; see abstract), the prior art addresses the notion of a medicine comprising the lipid nanoparticles, as per claims 17-19.
Albertsen et al. does not teach a modified polysaccharide containing a hydrophobic group, wherein the hydrophobic group is a sterol skeleton and the polysaccharide is pullulan.
Mizuta et al. teaches, “Nanoscale biomembrane vesicles such as liposomes and extracellular vesicles are promising materials for therapeutic delivery applications” (Abstract)
Based on the desire for extracellular vesicles (EVs) to be “efficiently delivered to target tissues and cells”, “biomembrane engineering has recently been applied to develop methods of hybridizing various materials into EVs” (p. 1999, right col., 1st paragraph).
To that end, the reference teaches, “We previously reported the hybridization of EVs with functional inorganic particles by using nanogels formed by the self-assembly of cholesterol-bearing pullulan (CHP)” (p. 2000, left col., 2nd paragraph). Here, the cholesterol-bearing pullulan or CHP suffices as a modified polysaccharide containing a hydrophobic group, wherein the hydrophobic group is a sterol skeleton and the polysaccharide is pullulan.
In this case, the prior art teaches “hybridization of nanosized biomembrane vesicles and iron oxide nanoparticles using CHP nanogel as an interface” (p. 2000, right col., last paragraph). It was found that “during magnetic nanogel hybridization, the liposome retains its structure and hybridizes with the nanogel by non-covalent bonding” (p. 2006, right col., 1st full paragraph).
“This hybridization mechanism is expected to contribute to significantly to the retention of function in the hybridization of biomembrane vesicles and their inclusions” (p. 2009, left col.).
In regard to claim 11, Mizuta et al. teaches inserting “CpG oligodeoxynucleotides” into liposomes (p. 2000, right column, 2nd paragraph). Accordingly, it would have been obvious to use CpG oligo DNA as the nucleic acid in the liposomes of Albertsen et al.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to combine the CHP nanogel, i.e., the modified polysaccharide containing a hydrophobic group of Mizuta et al., with the lipid nanoparticles of Albertsen et al. for the advantage of contributing significantly to the retention of function in the biomembrane vesicles and their inclusions, as taught by Mizuta et al. The artisan would have reasonably expected success with the combination insofar as the vesicles of Albertsen et al. are nanosized lipid vesicles.
2) Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albertsen et al., (Advanced Drug Delivery Reviews 2022) and Mizuta et al. (Nanoscale Advances 2022, cited in IDS) as applied to claims 1-4, 6-11, 13-19 above, and further in view of Kondo et al., (Biomicrofluidics, 2010).
The combination of Albertsen et al. and Mizuta et al., which is taught above, differs from claim 5 insofar as it does not teach the molecular weight of pullulan in the CHP nanogel.
Kondo et al. teaches the use of “cholesterol-bearing pullulan (CHP) nanogels” for DNA separation. (Abstract).
In the CHP nanogel, “[t]he average molecular weight (Mw of pullulan was 1.08X105” (p. 2, Nanogel preparation).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use pullulan having an average molecular weight of 5000 to 2,000,000, as claimed, in the nanogels of Mizuta et al. since pullulan with molecular weight within the claimed range, i.e., 1.08X105 (108 000) Daltons, was known to be suitable for CHP nanogels, as taught by Kondo et al.
3) Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Albertsen et al., (Advanced Drug Delivery Reviews 2022) and Mizuta et al. (Nanoscale Advances 2022, cited in IDS) as applied to claims 1-4, 6-11, 13-19 above, and further in view of Tenchov et al., (AcsNano, 2021).
The combination of Albertsen et al. and Mizuta et al., which is taught above, differs from claim 12 insofar as it does not teach the ionized lipids of claim 12, e.g., formula 1.
Tenchov et al. teaches a report on lipid nanoparticles including recent advancements (Abstract).
The reference teaches suitable lipid constituents for lipid nanoparticles such as (4-hydroxybutyl)azanediyl bis(hexane-6,1-diyl)bis(2-hexyldecanoate) also known as ALC-0315. ALC-0315 is an ionizable cationic lipid with the following structure according to formula 1, as claimed:
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(p. H, Figure 8).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use ALC-0315 as the lipid in the lipid nanoparticles of Albertsen et al. based in its art recognized suitability for its intended use if lipid nanoparticles, as taught by Tenchov et al. The artisan would have reasonably expected success with the combination insofar as the lipid nanoparticles of Albertsen et al. utilize ionizable lipids, and the lipid of Tenchov et al. is ionizable.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612