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 .
Priority
This application is a National Stage entry of PCT/US2022/026398, filed 04/26/2022, and claims priority from Provisional Application 63179942, filed 04/26/2021.
Information Disclosure Statement
The IDS filed on 10/25/2023 has been considered. See the attached PTO 1449 form.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12) in the reply filed on 11/17/2025 is acknowledged.
Claims 14-15 and 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Status
Receipt of Remarks filed on 11/17/2025 is acknowledged. Claims 1-12, 14-15, 17-22 are currently pending. Claims 14-15, 17-22 have been withdrawn. Accordingly, claims 1-12 are currently under examination.
Claim Objections
Claims 10 and 11 are objected to because of the following informalities:
In claim 10, the recitation “by direction translocation” should recite “by direct translocation”.
In claim 10, the recitation “cytoplasmatic membrane” should recite “cytoplasmic membrane”.
In claim 11, the recitation “at least of an” should recite “at least one of an”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-12 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.
Claim 1 recites “wherein the nanocarrier is selected from the group consisting of SPIO-Au, SPIO-Au-RhB, SPIO-Au-RhB-PCC-2, SPIO-Au-Py, SPIO-Au-Py-PCC-3, and combinations thereof”. Firstly, it is unclear in this recitation as to which component is the shell, the core and the functionalized surface because the claim requires the nanocarrier comprises a shell, a core and the shell comprising a functionalized surface. For example, in SPIO-Au, it is unclear which component is the core, which is the shell and the functionalized surface. Further, the other alternative nanocarriers (e.g. SPIO-Au-RhB-PCC-2) also make it unclear as to which component is the shell, the core and the functionalized surface because the claim does not specify which component in this is the core, the shell and the functionalized surface. For example, is the SPIO-Au the core or only the SPIO is the core and the Au is the shell. Also, is the Au-RhB-PCC-2 the shell, the core or the functionalized component? Also, in SPIO-AU, there appear to be only 2 components (e.g. SPIO as the core and Au as the shell) and the claim requires the nanocarrier comprises a shell, a core and the shell comprising a functionalized surface, and it is unclear whether the claim requires a functionalized surface because the “SPIO-Au” nanocarrier recited in the claim does not recite a functionalized surface. Additionally, the recitation “and combinations thereof” also makes the claim indefinite because the claim is directed to A nanocarrier and the recitation “combinations thereof” suggests there are combination of different nanocarriers. Therefore, the recitation “combination thereof” makes the metes and bounds of the claim unclear because it is unclear to the examiner as to whether the claim is directed to a single nanocarrier or whether the claim is directed to a product which comprises multiple different types of nanocarriers.
Claims 1 and 6 recite “PCC-2” and “PCC-3”. While the claims and the instant specification clearly define and disclose that PCC is a porous coordination cage. The claims or the specification do not clearly define what exactly constitutes PCC-2 and PCC-3. Claims 1 and 6 are rendered indefinite because in the specification, there is no clear definition of what exactly constitutes PCC-2 and PCC-3.
Claims 2-5 and 7-12 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
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.
(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 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nassireslami et al. (Adv Pharm Bull, 2018, 8(2), 201-209)(cited in IDS).
Nassireslami throughout the reference teaches gold coated Superparamagnetic Iron Oxide Nanoparticles as effective nanoparticles to eradicate breast cancer cells via photothermal therapy.
Regarding claims 1 and 7-8, Nassireslami teaches a nanocarrier wherein Fe2O3 nanoparticles was prepared via microemulsion method and their surface was modified via gold. Gold coated gamma-Fe203 nanoparticles were formed. This provides a gold-coated (metal shell) SPION (SuperParamagnetic Iron Oxide Nanoparticles, which reads on the core of instant claims). SPIONs are important nano-carriers that have greatly attracted researchers’ attention due to their various functionality such as imaging, drug delivery, gene delivery, and hyperthermia. Nassireslami teaches developing SPIONs via microemulsion method and modifying the surface of NPs with gold (i.e., SPIO-Au nanocarrier recited in claim 1). The DNA based MUC-1 aptamer was conjugated on the surface of nanoparticles to increase specificity of nanoparticles delivery into cancerous cells. The gold layer provides easy attachment with thiol conjugated agents. The aptamer conjugated on the surface of the nanoparticles (i.e. gold coated SPION) reads on wherein the shell comprises a functionalized surface. (see e.g., abstract; title; pg 201, col 1, para 1; pg 201, col 2, para 2; pg 202, col 2, para 1; pg 203, col 2, para 4; entire document).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-4, 6, 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nassireslami et al. (Adv Pharm Bull, 2018, 8(2), 201-209)(cited in IDS) as applied to claims 1 and 7-8 above, and further in view of Fang et al. (Small 2018, 14, 1802709).
The teachings of Nassireslami have been set forth above.
As discussed supra, Nassireslami teaches the DNA based MUC-1 aptamer was conjugated on the surface of nanoparticles to increase specificity of nanoparticles delivery into cancerous cells. The gold layer provides easy attachment with thiol conjugated agents and aptamer was modified with thiol. The aptamer conjugated on the surface of the nanoparticles (i.e. gold coated SPION) reads on wherein the shell comprises a functionalized surface. Nassireslami teaches the aptamer is attached to the gold shell via thiol (i.e., bridge as recited in the instant claims) because the gold layer provides easy attachment with thiol conjugated agents and aptamer was modified with thiol. Thus, Nassireslami teaches the bridge which comprises thiol as recited in claims 2 and 4.
Nassireslami does not teach wherein the functionalized surface comprises at least one porous coordination cage (PCC) (claim 2), wherein the PCC comprises a metal cluster and an organic linker (claim 3), wherein the PCC is at least one of PCC-2 or PCC-3 (claim 6). Nassireslami also does not expressly teach the limitations recited in claims 9-12. However, Fang et al. cures these deficiencies.
Fang teaches porous coordination cages (PCCs) have great potential for use in cancer nanotherapy and to elucidate fundamental insight regarding subcellular compartment targeting. When a specific bioactive agent was brought to its targeting site by PCC, the anticancer efficacy was dramatically improved. Porous coordination cages (PCCs) are nanoscopic structures assembled by metal clusters and organic linkers. Fang specifically discloses PCC-2 and PCC-3 as the types of porous coordination cages (PCCs) which are used and this reads on claim 6. PCCs can carry (encapsulate) guest molecules within their cavities and can release guest molecules as a result of their reversible bonds. Specifically, camptothecin (CPT) anticancer drug was encapsulated in the PCC-2 and PCC-3, which reads on claim 9. Fang also teaches the PCCs penetrate cytoplasmic membrane by direct translocation as recited in claim 10. Regarding claim 12, as discussed above, Fang teaches camptothecin (CPT) anticancer drug was encapsulated in the PCC-2 and PCC-3 and therefore, it would necessarily be capable of being released upon excitation of the nanocarrier via a light source. (see e.g., Title; Abstract; Introduction; Results and Discussion; Conclusion; page 7; section 2.2 and 2.4; Entire document).
It would have been prima facie obvious to one of ordinary skill in the art to have combined the teachings of Nassireslami and Fang and functionalize the surface of the gold shell of Nessireslami with porous coordination cage (PCC) and specifically with PCC-2 or PCC-3, which comprise comprises a metal cluster and an organic linker. One would have been motivated to do so because Fang teaches porous coordination cages (PCCs) such as PCC-2 or PCC-3 have great potential for use in cancer nanotherapy and to elucidate fundamental insight regarding subcellular compartment targeting and when a specific bioactive agent was brought to its targeting site by PCC, the anticancer efficacy was dramatically improved. Fang also teaches the porous coordination cages (PCCs) are nanoscopic structures assembled by metal clusters and organic linkers and PCCs can carry (encapsulate) guest molecules within their cavities and can release guest molecules as a result of their reversible bonds. Specifically, camptothecin (CPT) anticancer drug was encapsulated in the PCC-2 and PCC-3. Fang also teaches the PCCs penetrate cytoplasmic membrane by direct translocation. As discussed supra, Nassireslami teaches gold coated Superparamagnetic Iron Oxide Nanoparticles as effective nanoparticles to eradicate breast cancer cells via photothermal therapy. The DNA based MUC-1 aptamer was conjugated on the surface of nanoparticles to increase specificity of nanoparticles delivery into cancerous cells. Nassireslami teaches gold coated SPIO nanoparticles functionalized with aptamer to fight against cancerous cells and Fang teaches PCC dramatically enhanced anticancer efficacy. As such, it would have been obvious to one skilled in the art to utilize PCC and functionalize the nanoparticle of Nassireslami with PCC because PCC is also taught to enhance anticancer efficacy and PCC is capable of encapsulating anticancer drug (CPT) for delivering the drug to the target cancerous cell.
Regarding claim 11, the claim is directed to methods of forming the functionalized surface of the shell. However, the claims are directed to a product and the product taught by the cited prior art teaches structurally the same product as recited in the instant claims. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Further, Fang teaches PCC-2 being anionic in nature and the PCC taught by prior art would be capable of forming the functionalized surface of the shell through an anionic exchange resin assisted method (see e.g. page 7, right column).
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Allowable Subject Matter
Claim 5 is only rejected under 112(b) and would be allowable if those issues are resolved and if the limitations of claim 5 are incorporated into independent claim 1.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616