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 Group I (claims 1-9, 11, 15, 24-25, 30, 49-50, and 53-57) and the species of vehicle form (silicasome), TLR agonist (telratolimod), and chemotherapeutic agent (irinotecan) in the reply filed on 22 June 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Claims 61 and 63-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of vehicle form, there being no allowable generic or linking claim. Claim 25 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of TLR agonist, there being no allowable generic or linking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 1-4, 6-9, 11, 15, 24, 30, 49-50, and 53-57 are rejected under 35 U.S.C. 103 as being unpatentable over Mei et al. (US Patent Application Publication 2020/0197534) in view of Wightman (US Patent Application Publication 2013/0230578).
Mei et al. discloses technology for facilitating immune therapy in cancer treatments (abstract). One disclosed embodiment (paragraph [80]) has a mesoporous silica nanoparticle having pores suitable to receive molecules, as well as a lipid bilayer coating the silica nanoparticle. Further, the embodiment has an ICD agent disposed within the silica nanoparticle. Examples of ICD agents taught by Mei et al. include irinotecan (paragraph [12]), and this is the elected species of chemotherapeutic agent.
Instant claim 1 recites that a lipid compatible TLR agonist is present as well (in the lipid bilayer), While Mei et al. suggests including adjuvants (section starting at paragraph [418]), the specific TLR as instantly recited (such as the elected species of telratolimod) is not taught.
Wightman discloses compounds useful for enhancing immune response, and which can be used as a vaccine adjuvant and a cancer treatment (abstract). The compound disclosed (claim 1) is telratolimod, and is the elected species of TLR agonist. Wightman teaches that this compound is surprisingly effective in boosting localized immune response with reduced systemic TNF induction (paragraph [7]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included telratolimod into the composition taught by Mei et al. Doing so would provide the benefits taught by Wightman (this compound is surprisingly effective in boosting localized immune response with reduced systemic TNF induction). Further, 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, the vehicle recited by independent instant claim 1 is rendered prima facie obvious.
Instant claims 2, 6-9, 11, 15, and 24 further limit the TLR agonist, and the above cited compound (telratolimod) reads upon the instantly recited limitations.
Instant claims 3-4 further limit the nanoparticle core, and the mesoporous silica nanoparticle taught by Mei et al. reads upon these limitations.
Instant claim 30 further limits the lipid bilayer, and the inclusion of phospholipids is suggested by Mei et al. (paragraph [31]).
Instant claims 49 and 50 recite the further inclusion of a cargo trapping agents. And Mei et al. suggests the inclusion of such an ingredient (paragraph [61]).
Instant claim 53 further recites there is a targeting moiety conjugated to the drug carrier. And Mei et al. suggests including such moieties (paragraph [64]).
Instant claims 54-55 further limit the colloidal stability properties for the carrier. And such is taught by Mei et al. (paragraph [75]).
Instant claims 56-57 further limit the composition to having a carrier and being formulated for specific administration. And such is taught by Mei et al. (paragraphs [178-179]).
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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