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, the species of silica with cavities, and dichloro(1,2-diaminocyclohexane) platinum in the reply filed on 31 March 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Claims 111 and 150 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 11-12, 18, 20, 69, and 72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of drug, there being no allowable generic or linking claim.
Claim Objections
Claim 66 is objected to because of the following informalities. The claim recites two acronyms but does not spell them out or otherwise define them (EE & LC). Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Improper Dependent Claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 appears to restate thew same limitations which are already present in parent claim 1, and thus does not further the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 21, 31-32, 66, 99, and 104 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nel et al. (US Patent Application Publication 2018/0098945).
Nel et al. discloses mesoporous silica nanoparticles with a lipid bilayer coating thereon for cargo delivery, where the cargo can be a drug (title & abstract). The silica nanoparticle has pores that receive the cargo, and the lipid bilayer coats the surface of the nanoparticles and stably seals the pores (abstract & claim 134).
Instant claim 1 further limits the drug to metal-based drugs. Nel suggests that the drug can comprise oxaliplatin (paragraphs [105-107] & [333]). Oxaliplatin is a platinum-based drug. Thus, the silica nanoparticles disclosed by Nel et al. anticipate the drug-delivery system recited by independent instant claim 1 and dependent claim 21.
Instant claims 2 and 4 further limit the metal-based drug, and the cited oxaliplatin reads upon these limitations.
Instant claims 31-32 further limit the nanoparticle, and the mesoporous silica nanoparticle disclosed by Nel et al. reads upon these limitations.
Instant claim 66 further limits the location of the drug (entrapped in the nanoparticle or not), and the localization of the drug in the nanoparticle, in the overall composition, or both is suggested by Nel et al. (paragraph [383]). Thus, the localization of the drug just in the nanoparticle is suggested therein.
Instant claim 99 recites several alternative limitations, and the colloidal stability disclosed by Nel et al. (paragraph [paragraph [37]) reads upon this instant claim.
Instant claim 104 recites that the drug delivery vehicle (the nanoparticles ) and mixed with a carrier, and this is suggested by Nel et al. (paragraph [149]).
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 40, 42, 46, 50-53, 57, and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Nel et al. (US Patent Application Publication 2018/0098945).
Nel et al. discloses mesoporous silica nanoparticles with a lipid bilayer coating thereon for cargo delivery, where the cargo can be a drug (title & abstract). The silica nanoparticle has pores that receive the cargo, and the lipid bilayer coats the surface of the nanoparticles and stably seals the pores (abstract & claim 134). Nel suggests that the drug can comprise oxaliplatin (paragraphs [105-107] & [333]). Oxaliplatin is a platinum-based drug.
Instant claims 40, 42, and 50-52 also further limit the lipid bilayer. Nel et al. suggests the lipid bilayer have lipids such as DSPC, cholesterol, and DSPE-PEG in a molar ratio of 3:2:0.15(claim 140), which read upon these limitations.
Thus, Nel et al. discloses compositions comprising the individual elements of the instantly recited combination (the specific lipids and specific drug) and together these would provide a composition as instantly claimed. However, Nel et al. is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been prima facie obvious, however, to make the combination since each component is taught as being useful in making the compositions of the prior art. Since this modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions a prima facie case of obviousness exists. See MPEP 2141.
Instant claim 46 further limits the PEG-lipid, and Nel et al. suggests mPEG-lipids with a molecular weight of, for example 5000 (paragraph [311]), which reads upon this limitation.
Instant claims 53 and 57 further limit the lipids present, and Nel et al. suggests that PEGylated lipids be included (paragraph [306]), and lipids include cholesterol (paragraph [213]), thus reading upon these limitations.
Instant claim 91 recites the further limitation that there is a targeting moiety conjugated to the drug carrier, and such a feature is disclosed by Nel et al. (paragraph [12]).
Claim 5 is rejected (and above discussed claims 1-2, 4, 21, 31-32, 40, 42, 46, 50-53, 57, 66, 91, 99, and 104 are rejected) under 35 U.S.C. 103 as being unpatentable over Nel et al. (US Patent Application Publication 2018/0098945) as applied to claim 1 above, and further in view of Liu et al. (US Patent Application Publication 2016/0361268).
Nel et al. discloses all of the features recited by instant claim 5 except for the species of platinum drug instantly recited. Nel et al. suggests including the anticancer drug oxaliplatin and also including drugs useful for the treatment of cancer (paragraph [333]) but does not suggest the specific drugs recited by instant claim 5.
Liu et al. discloses treatments of cancer using drugs such as oxaliplatin and dichloro(1,2-diaminocyclohexane) platinum (abstract), which is the elected species of drug.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included dichloro(1,2-diaminocyclohexane) platinum as the anticancer drug in the composition disclosed by Nel 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.
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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