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.
Claim Status
Receipt of Remarks filed on 5/7/2026 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 Claims 14-15, 17-22 have been withdrawn.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.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New/Maintained Claim(s) Objection(s)/Rejection(s)
Claim Objections
Claim 1 is objected to because of the following informalities:
In the last line of claim 1, there should be a conjunction (e.g. “and”) between “SPIO-Au-PY” and “SPIO-Au-PY-PCC-3”.
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 (e.g. paragraph 0030 of specification states “(SPIO-Au) core-shell” and in the same paragraph it is also stated “SPIO-Au core” which suggests SPIO and Au is part of the core). 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.
Claims 2-12 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 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.
Response to Arguments
Regarding the rejection under 112(b), Applicant argued the naming convention employed in claim 1 follows a well-understood convention in the nanoparticle arts, where the components are listed in order from the innermost to the outermost structural element. Specifically, "SPIO" refers to the superparamagnetic iron oxide core, and "Au" refers to the gold shell surrounding the core. This core-shell nomenclature is consistent with the disclosure in the specification and is widely understood by those of ordinary skill in the art. Applicant argued that examiner's own citation to Nassireslami et al. confirms that gold-coated superparamagnetic iron oxide nanoparticles are well-recognized in the art, where the SPIO serves as the core and the gold layer serves as the shell. For the more complex nanocarrier designations in the Markush group (e.g. SPIO-Au- RhB-PCC-2), the SPIO is the core, Au is the shell, and RhB-PCC-2 denotes the functionalized surface comprising rhodamine B and the porous coordination cage PCC-2. A person of ordinary skill in the art would readily understand this structural hierarchy from the naming convention. Regarding whether the claim requires a functionalized surface, given that "SPIO-Au" appears to recite only two components, applicant argued that the SPIO-Au nanocarrier, to fall within the scope of claim 1, must also comprise a shell having a functionalized surface. The gold shell in SPIO-Au inherently provides reactive surface sites that can be functionalized.
In response, as discussed supra, paragraph 0030 of specification states “(SPIO-Au) core-shell” and in the same paragraph it is also stated “SPIO-Au core” which suggests SPIO and Au is part of the core. Thus, the specification also make it unclear whether the SPIO-Au is the core or only the SPIO is the core and the Au is the shell. Further, Nassireslami does not use the same naming as recited in the instant claims (e.g. SPIO-Au) but rather clearly teaches gold is coated on superparamagnetic iron oxide nanoparticles. There are nanoparticles well known in the art which use Au (gold) as the core and the claims in light of the specification are unclear as to whether SPIO is the core and Au is the shell or whether both SPIO-Au are the core. Further, as discussed supra, 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? If the SPIO-Au is the core (as stated in paragraph 0030 of specification), then RhB would be the shell and PCC-2 would be the functionalized component based on the naming convention method argued by applicant, however, applicant appear to suggest RhB-PCC-2 denotes the functionalized surface. Thus, there is unclarity as to what is the core, the shell and the functionalized component in these nanocarrier recited in claim 1. Regarding the argument that the SPIO-Au nanocarrier, to fall within the scope of claim 1, must also comprise a shell having a functionalized surface and that the gold shell in SPIO-Au inherently provides reactive surface sites that can be functionalized, the examiner argues the claim requires the nanocarrier comprises a shell, a core and the shell comprising a functionalized surface, and the claim recites the specific type of nanocarrier in the Markush group. However, in SPIO-AU, there appear to be only 2 components (e.g. SPIO as the core and Au as the shell; or both SPIO-Au as the core) and it is unclear whether the claim requires a functionalized surface because the “SPIO-Au” nanocarrier (which can be the core or core-shell as suggested in the specification) recited in the claim does not recite a functionalized surface. Further, while the gold shell in SPIO-Au may inherently provide reactive surface sites that can be functionalized, the claim recites the shell comprises a functionalized surface (which is not the same a surface which can be functionalized) and the SPIO-Au carrier does not appear to include a functionalized surface. Therefore, applicant’s arguments regarding the 112(b) rejections are not found persuasive at this time.
Regarding the rejection under 102, applicant argued that claim 1 requires that the nanocarrier be selected from the group consisting of SPIO-Au, SPIO-Au-RhB, SPIO-Au-RhB-PCC-2, SPIO-Au-Py, SPIO-Au-Py-PCC-3. The term "SPIO-Au" refers to a nanocarrier having a superparamagnetic iron oxide core and a gold shell that is configured to support the specific types of functionalization, namely, functionalization involving porous coordination cages (PCCs), rhodamine B (RhB), and pyrene (Py) moieties, attached via specific bridge compounds such as thiol-containing bridges. Applicant argued that Nassireslami's aptamer-functionalized surface is structurally and functionally distinct from the functionalized surface of the claimed nanocarriers. It was argued that the broadest reasonable interpretation of functionalized surface in claim 1, read in light of the specification and the dependent claims, encompasses a surface modified with specific chemical moieties for cargo delivery and light-triggered release, not a surface modified with a biological targeting agent such as an aptamer.
Further, while the claims are read in light of the specification, the disclosure in the specification is not incorporated into the claims.
In response, while the claims are read in light of the specification, the disclosure in the specification is not incorporated into the claims. Instant claims 1 and 7-8 rejected under 102 require a nanocarrier comprising a shell and a core disposed within the shell, wherein the shell comprises a functionalized surface, wherein the shell is a metal shell and the core is a superparamagnetic iron oxide (SPIO). SPIO-Au recited as one of the nanocarrier also does not require any specific functionalized component. As discussed supra, Nassireslami teaches gold coated Superparamagnetic Iron Oxide Nanoparticles and the aptamer conjugated on the surface of the nanoparticles (i.e. gold coated SPION) reads on wherein the shell comprises a functionalized surface. Claims 1 and 7-8 do not require any specific type of functionalized component (e.g. such as PCC recited in claim 2) and therefore, the aptamer conjugated on the surface of the nanoparticles (i.e. gold coated SPION), as taught by Nassireslami, reads on wherein the shell comprises a functionalized surface.
Regarding the rejection under 103, applicant argued that Nassireslami is directed to photothermal therapy using gold-coated SPIO nanoparticles functionalized with a DNA-based aptamer for targeted delivery to breast cancer cells. The surface functionalization in Nassireslami (aptamer conjugation) is optimized for this photothermal therapeutic approach. It was argued that Fang on the other hand, is directed to porous coordination cages (PCCs) as free-standing molecular cargo vectors for intracellular delivery. The PCCs in Fang are not used in conjunction with metallic core-shell nanoparticles. Applicant argued that one skilled in the art would not have been motivated to take Nassireslami's aptamer-targeted, photothermal-based nanoparticle system and graft onto it the PCCs of Fang, which operate through chemotherapeutic drug encapsulation and controlled release driven by PCC structure and charge properties.
In response, Nassireslami teaches that to improve the accumulation of NPs in the desired tissue, they can be conjugated with various functional moieties. Nassireslami teaches that gold coated NP was further modified with MUC-1 aptamer as a targeting agent to increase drug delivery into the desired tissue (see e.g. abstract; introduction). As acknowledged by applicant, Fang also teaches use of PCCs as cargo vectors for tumor tissue drug delivery. Fang also discloses that thermogravimetric analysis was used to indicate that all three of the PCCs are thermally stable up to 440 °C. (see e.g. section 2.2; results and discussion of Fang). Therefore, it would have been obvious to one skilled in the art to replace the aptamer with the PCC of Fang because the gold coated NP of Nassireslami was modified with MUC-1 aptamer as a targeting agent to increase drug delivery into the desired tissue and Fang also teaches use of PCCs as cargo vectors for tumor tissue drug delivery and that PCCs are also thermally stable. Further, as discussed supra, 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. As discussed supra, Nassireslami teaches gold coated Superparamagnetic Iron Oxide Nanoparticles as effective nanoparticles to eradicate breast cancer cells and the MUC-1 aptamer was conjugated on the surface of nanoparticles to increase drug 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.
Applicant argued that replacing or supplementing the aptamer functionalization with PCCs as proposed by the Examiner would alter the fundamental targeting mechanism of Nassireslami's system. Attaching PCC’s charged structures to the gold surface of Nassireslami's nanoparticles would likely interfere with the aptamer targeting, alter the surface charge and colloidal stability of the nanoparticles, and fundamentally change the biodistribution and therapeutic mechanism of the system. A person of ordinary skill in the art would recognize that such modifications would likely undermine the targeting specificity that is central to Nassireslami's system, and would therefore not be motivated to combine the references in the proposed manner.
In response, as discussed supra, firstly the examiner argues that it would have been obvious to one skilled in the art to replace the aptamer with the PCC of Fang because the gold coated NP of Nassireslami was modified with MUC-1 aptamer as a targeting agent to increase drug delivery into the desired tissue and Fang also teaches use of PCCs as cargo vectors for tumor tissue drug delivery and that PCCs are also thermally stable. As mentioned previously, both aptamer and PCC are taught to be used for delivering drug into the target cancerous tissue and thus one would have found it obvious to utilize PCC in place of aptamer on the SPIO-Au nanoparticle as both are taught to be useful for similar function. Thus, one skilled in the art would not necessarily have both aptamer and the PCC on the SPIO-Au nanoparticle and as such the PCC would not interfere with the aptamer targeting. Further, the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01. Applicant make the argument that attaching PCC’s charged structures to the gold surface of Nassireslami's nanoparticles would likely interfere with the aptamer targeting, alter the surface charge and colloidal stability of the nanoparticles, and fundamentally change the biodistribution and therapeutic mechanism of the system. However, applicant have not provided any evidence or an explanation of why this would occur or why one skilled in the art would expect this occur and thus be dissuaded from utilizing the PCC of Fang with the nanoparticle of Nassireslami.
Applicant further made similar assertions and argued that attaching PCCs to the surface of a gold-coated nanoparticle would introduce significant structural and chemical challenges, including maintaining the structural integrity of the PCC cage when tethered to a metallic surface, preserving the cargo encapsulation and release properties of the PCC when constrained on a nanoparticle surface rather than freely dissolved, and ensuring that the bridge chemistry used to attach the PCC to the gold shell does not interfere with the PCC's guest molecule encapsulation capability.
In response, as discussed supra, Nassireslami teaches the gold layer provides easy attachment with thiol conjugated agents and aptamer was modified with thiol and Fang teaches porous coordination cages (PCCs) are nanoscopic structures assembled by metal clusters and organic linkers. As evidenced by Encyclopedia of Material (Encyclopedia of Materials: Science and Technology; ISBN: 0-08-0431526; pp. 9323-9332; 2001), thiol group can be used to make a chemical attachment with metal clusters. (see e.g. section 2.5). Also, as evidenced by Azcarate (J. Phys. Chem. Lett. 2013, 4, 3127-3138), thiol molecules bind to metallic clusters, leading to thiolated protected NPs (see e.g. pg 3128, left column). The evidence in the art suggests that thiols can bind to / make chemical attachment with metal cluster which lead to thiolated protected NPs. While applicant make the assertions discussed above in their argument, applicant have not provided any evidence as to why one would not have a reasonable expectation of success in utilizing PCCs instead of aptamer onto the gold layer with thiols of the NP taught in Nassireslami, especially because the evidence in the art suggests that thiols can bind to / make chemical attachment with metal cluster which lead to thiolated protected NPs. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01. Also, as discussed supra, Nassireslami teaches the NPs can be conjugated with various functional moieties and applicant in the remarks also acknowledge the gold shell in SPIO-Au inherently provides reactive surface sites that can be functionalized, as is well known in the art (e.g. page 6 of remarks). Thus, one skilled in the art would have had a reasonable expectation of success.
Applicant further argued that the process limitations of claim 11, formation of the functionalized surface by an anionic exchange resin assisted method or a direct exchange method, impart structural characteristics to the resulting product that are distinct from products formed by other methods.
In response, as discussed supra, 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). Applicant have not provided any persuasive argument or evidence as to how the product taught in the prior art is structurally different from the nanocarrier recited in the claims. Further, as discussed previously, 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).
With respect to claim 12, applicant argued that Fang does not teach light-triggered drug release from PCCs. The drug release mechanism described in Fang is pH-dependent, occurring in acidic environments over periods of hours to days. Light-triggered release is a distinct mechanism that requires specific structural and photophysical properties of the nanocarrier system. The combination of a gold shell with PCC-functionalized surface to achieve light-triggered release is a unique feature of the claimed invention that is not taught by the combination of Nassireslami and Fang.
In response, the examiner argues that claim 12 recites an intended use of the product. The cited prior art teaches structurally the same product as recited in the instant claims and Fang also 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.
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
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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/ALI S SAEED/Examiner, Art Unit 1616
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