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.
Information Disclosure Statement
The Examiner notes that no information disclosure statement has been filed in this application. Applicant is reminded that in nonprovisional applications, applicants and other individuals substantively involved with the preparation and/or prosecution of the application have a duty to submit to the Office information which is material to patentability as defined in 37 CFR 1.56.
Election/Restrictions
Applicant’s election without traverse of the species of compound of formula (1) (octadecyl gallate), the ionizable lipid (compound 13), and the helper lipid (DSPC) in the reply filed on 08 September 2026 is acknowledged.
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 1-4, 6-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Besin et al. (US Patent Application Publication 2019/0314291) in view of Sabir et al. (Pharmaceuticals, 2021, vol. 14, page 696).
Besin et al. discloses lipid nanoparticle compositions that allow for enhanced delivery of nucleic acids such as RNA (abstract). The lipid nanoparticle comprises an ionizable lipid, a phospholipid, and optionally a PEG-lipid (claim 1). The phospholipid can be DSPC (claim 42), and this is the elected species of helper lipid.
Besin et al. does not disclose the inclusion of a compound of Chemical Formula (1), which is a limitation recited by independent instant claim 1.
Sabir et al. discloses lipid nanoparticles and that the inclusion of n-propyl gallate into this allows for improvement in delivery (lower burst and sustained delivery (abstract). This compound reads upon the instantly recited compound of Chemical Formula (1) (specifically Chemical Formula 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included the gallate compound taught by Sabir et al. Doing so would provide the benefit taught by Sabir et al.
Instant claims 2 and 3 further limit the compound of Chemical Formula (1), and are read upon by the compound suggested by Sabir et al.
Instant claims 4, 6-11, and 14 recite further limitations to the additional lipids, and the above cited combination taught by Besin et al. reads upon these limitations.
Instant claim 12 recites limitations to the amounts of the lipids present. The lipids suggested by Besin et al. are in amounts overlapping the instantly recited amounts (claim 56). 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. And as for the concentration of the compound of Chemical Formula (1), Generally, differences in concentration and tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A).
Instant claims 15-18 recite further limitations to the active agent and its effect, and use for vaccination (paragraph [198]) to deliver mRNA (claim 2) is taught by Besin et al.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter. The elected species of Chemical Formula (1) (specifically Chemical Formula (5)) is not suggested by the prior art for use in solid lipid nanoparticles. While such a compound is known, it is not suggested for use in this application. Also, the combination of compounds of Chemical Formula (1) with the ionizable lipids recited by instant claim 7 in solid lipid nanoparticles is also not suggested by the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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