DETAILED ACTION
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 . 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.
Election/Restrictions
Applicant’s election of species in the reply filed on 06 May 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of second lipid, there being no allowable generic or linking claim.
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.
Claims 1-13, 15-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Prieve et al. (US Patent Application Publication 2018/0221402) in view of Keil et al. (US Patent Application Publication 2016/0303047).
Prieve et al. discloses methods of delivering agents into cells using lipid nanoparticles (abstract). The lipid nanoparticles are substantially neutral and have a size of between 30 and 150 nm (paragraph [251]).)
One such lipid nanoparticle disclosed has a polynucleotide and a mixture of lipid components (claim 241). The lipids include from about 35 to about 55 mol% of a cationic lipid, from about 25 to about 40 mol% of an ionizable anionic lipid, from about 5 to about 20 mol% of a helper lipid, and from about 5 to about 15 mol% of a PEG lipid (id.).
Prieve et al. suggests cholesteryl hemisuccinate as the anionic lipid (paragraph [239]), which reads upon the instantly recited first lipid. This is also the elected species of first lipid.
Instant claims 2 and 5-8 recite the inclusion of a third lipid, which can be cholesterol, and a fourth lipid, which can be mPEG2000-DMPE. The helper lipid suggested by Prieve et al. can be cholesterol (paragraph [240]), which thus reads upon the instantly recited third lipid. And methoxy-PEG2000-DMPE is suggested as a PEG lipid by Prieve et al. (paragraph [241]), which reads upon the fourth lipid.
Prieve et al. suggests the inclusion of a cationic lipid, but does not suggest the inclusion of β-(L-arginyl)-L-2,3-diamino propionic acid-N-palmityl-N-oleyl amide as the second lipid.
Keil et al. discloses lipid composition comprising a cationic lipid (claim 122), and these are useful for delivering nucleic acids (claim 133). One specific cationic lipid taught useful is β-(L-arginyl)-L-2,3-diamino propionic acid-N-palmityl-N-oleyl amide (claim 129), which is the elected species of second lipid. These can be used in lipid particles (paragraph [100]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used the cationic lipid taught by Keil et al. as the cationic lipid in the lipid nanoparticle taught by Prieve et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Thus, independent instant claim 1 and dependent instant claims 3-4, and 15 are rendered prima facie obvious.
Instant claims 2, 5-8, and 17-18 further limit the four lipids, and are read upon by the above cited lipids.
Instant claims 9 and 10 further limit the amounts of the lipids, and are at least overlapped by the amounts suggested by Prieve et al. And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05.
Instant claims 11-12, 16, and 20 further limit the size and charge of the lipid nanoparticles, and are at least overlapped by the ranges suggested by Prieve et al.
Instant claim 13 further limits the polynucleotide delivered. And Prieve et al. suggests delivering mRNA (paragraph [250]).
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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