DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 02/18/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112 –
Indefiniteness and Broad to Narrow Limitations
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 1-4 and 7 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitations “central nervous system” and “lipid nanoparticle”, and the claim also recites “(CNS) and “(LNP)” which are the narrower statements of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parentheses from the claim.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Thibonnier et al (US 2015/0216892 A1), in view of Heim et al (US 2022/0162587 A1) and further in view of Zappavigna et al (Current Pharmaceutical Biotechnology, 2016, 17, 1-23).
Thibonnier taught miRNA (e.g., miR-603 taught at claim 9; see also ¶s 0011 and 0084]) encapsulated within nanoparticles, wherein the nanoparticle comprised a targeting agent bound to the outside [0063; see also ¶ 0019].
Although Thibonnier generally taught targeting agents, Thibonnier did not teach that the targeting agent: binds a polypeptide presented on a central nervous system cancer cell; comprised a polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 5, as instantly recited in claim 1.
Heim taught polyethyleneimine (PEI) as a cellular uptake agent, that encapsulates RNA, in order to promote the RNA’s ability to enter cells [0228].
Since Thibonnier taught encapsulated miRNA, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Thibonnier, PEI, as taught by Heim. The ordinarily skilled artisan would have been motivated to promote cellular uptake, as taught by Heim [0228].
The combined teachings of Thibonnier and Heim did not teach a polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 5
Zappavigna taught that cell-penetrating peptides (CPPs) mediate drug delivery by exploiting their ability to enter cells and enhance the uptake of cargo. The use of CPPs, conjugated to nanocarriers (NC) significantly improves NC delivery intracellularly, and thus readily contributes to the use of NCs for effective delivery of active agents [abstract and title]. At page 13 [left column, lines 1-14], Zappavigna taught that NCs functionalized with the CPP PR_b, which has the amino acid sequence (KSSPHSRNSGSGSGSGSGRGDSP), enhanced binding, intracellular uptake and delivery of cargo, compared with non-targeted NCs.
Since Thibonnier taught nanoparticles generally bound with targeting agents, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Thibonnier, the cell penetrating peptide Pr_b, which has the amino acid sequence (KSSPHSRNSGSGSGSGSGRGDSP), as taught by Zappavigna. The ordinarily skilled artisan would have been so motivated, because when conjugated to nanocarriers, (KSSPHSRNSGSGSGSGSGRGDSP) enhances binding, intracellular uptake and delivery of cargo, as taught by Zappavigna [page 13, left column, lines 1-14].
The instant claim 1 recites the amino acid sequence set forth in SEQ ID NO:5.
The instant Specification [page 2, line 16] disclosed SEQ ID NO:5 as the peptide having amino acid sequence KSSPHSRNSGSGSGSGSGRGDSP.
Zappavigna taught that the peptide Pr_b has amino acid sequence KSSPHSRNSGSGSGSGSGRGDSP.
It appears that the nanoparticles of the instant claims (nanoparticle comprising, as a targeting moiety, SEQ ID NO:5) and those of the prior art (nanocarrier conjugated with KSSPHSRNSGSGSGSGSGRGDSP) would reasonably be expected to have substantially the same physical and chemical properties (polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 5).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition (nanoparticle comprising, as a targeting moiety, peptide with SEQ ID NO:5) and its properties are inseparable. If the prior art teaches the identical chemical compounds (peptide having amino acid sequence KSSPHSRNSGSGSGSGSGRGDSP), then the properties (SEQ ID NO: 5) that the Applicant discloses and/or claims are necessarily present (see MPEP 2112).
Additionally, the instant claim 1 recites that the targeting moiety binds a polypeptide presented on a central nervous system cancer cell.
The originally filed disclosure [0006] states that lipid nanoparticles encapsulating miR-603 with polyethylenimine (miR-603/PEI complexes) can be functionalized with the peptide KSSPHSRNSGSGSGSGSGRGDSP (SEQ ID NO:5) to target and deliver the miR-603/PEI complexes to GBM cells such as GBM stem-like cells.
Thibonnier taught encapsulated miR-603. Heim taught PEI encapsulation of RNA. Zappavigna taught that the peptide Pr_b has amino acid sequence KSSPHSRNSGSGSGSGSGRGDSP.
It appears that the nanoparticles of the instant claims (nanoparticle comprising, as a targeting moiety, SEQ ID NO:5; comprising targeting moiety that binds a polypeptide presented on a CNS cancer cell) and those of the combined teachings of the prior art (nanocarrier conjugated with KSSPHSRNSGSGSGSGSGRGDSP; comprising encapsulated miR-603 and PEI) would reasonably be expected to have substantially the same physical and chemical properties (binds a polypeptide presented on a central nervous system cancer cell).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition (nanoparticle comprising peptide with SEQ ID NO:5; encapsulated with PEI and miR-603) and its properties are inseparable. If the prior art teaches the identical chemical compounds), then the properties (binds a polypeptide presented on a CNS cancer cell) that the Applicant discloses and/or claims are necessarily present (see MPEP 2112).
Thibonnier, in view of Heim and Zappavigna, reads on claim 1.
Claims 2-3 are rendered prima facie obvious because Thibonnier taught hsa-miR-603 [claim 9].
Claim 4 is rendered prima facie obvious because Thibonnier taught the nanoparticle as an exosome (e.g., reads on extracellular vesicle) [claim 25].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Thibonnier et al (US 2015/0216892 A1), in view of Heim et al (US 2022/0162587 A1), further in view of Zappavigna et al (Current Pharmaceutical Biotechnology, 2016, 17, 1-23) and further in view of Lipke et al (US 2020/0222596 A1).
The 35 U.S.C. 103 rejection over Thibonnier, in view of Heim and Zappavigna, was previously discussed.
The combined teachings of Thibonnier, Heim and Zappavigna did not teach the hydrophobic tail (C16)2-Glu-C2, as recited in claim 7.
Lipke taught (C16)2-Glu-C2-KSSPHSRNSGSGSGSGSGRGDSP (PRb) [0010, 0084], which has superior cell binding affinity [0011, 0014].
Since the combined teachings of Thibonnier, Heim and Zappavigna taught the peptide KSSPHSRNSGSGSGSGSGRGDSP, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of Thibonnier, Heim and Zappavigna, the hydrophobic tail (C16)2-Glu-C2, as taught by Lipke. The ordinarily skilled artisan would have been motivated to enhance cell binding, as taught by Lipke et al [0010-0011, 0014].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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