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 .
Election/Restrictions
Applicant’s election of Group I, claims 1, 2, 4, 7, 8, 10, 11 and 16 in the reply filed on 4/1/2026 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)).
Claims 3, 5 and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/1/2026.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 7, 8, 10, 11 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Du et al. (WO 2021/178623 A1).
Regarding claims 1 and 2, Du et al. teach a nanoparticle comprising a mRNA construct comprising:
a first mRNA sequence encoding an agent (an immunogenic polypeptide),
a second mRNA encoding a C3d;
wherein the first mRNA is operably linked via a linker to the second mRNA (parags. 11-14, 18 and 58).
Regarding claims 4 and 7, Du teaches that the nanoparticle can encode multiple antigens and comprises at least two mRNA constructs (parags. 56 and 57).
Regarding claim 8, Du teaches that in some embodiments the mRNA is linearized, thus the other embodiments encompass a circular mRNA (parag. 20).
Regarding claim 10, Du teaches that the nanoparticle is ionizable (parag. 61).
Regarding claim 11, Du teaches that the nanoparticle further comprises a therapeutic agent (parags. 56, 57 and 96).
Regarding claim 16, the specification teaches regarding chemically modified that “In some embodiments, the RNA can be chemically modified, for example to improve its properties, e.g, used to improve the properties and efficacy of the RNA. A number of chemical modification have been developed to improve the in vivo properties of nucleic acids. “(parag. 99 lines 1-4).
In this regard, Du teaches modifying their mRNA with nucleoside which will improve the properties and efficacy of RNA (parag. 102).
Thus the teachings of Du clearly anticipate the invention of claims 1, 2, 4, 7, 8, 10, 11 and 16.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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