DETAILED ACTION
Status of Application
Receipt of the Claim set filed 9/20/2024, is acknowledged.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 9-21 and 34-71 are cancelled.
Claims 1-8 and 22-33 are pending and currently under consideration.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The current claim set is drawn to a system and there are no method claims.
The following title is suggested: A PHOTORESPONSIVE DELIVERY SYSTEM BASED ON A MODIFIED PAMAM.
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.
Claim 6 is 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 pre-AIA the applicant regards as the invention.
The term "about" in the phrase “a diameter of about 20-200nm, or about 100-170 nm” in claim 6 is a relative term which renders the claims indefinite. The term "about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Appropriate correction is required.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“A Self-Assembled Coumarin-Anchored Dendrimer for Efficient Gene Delivery and Light-Responsive Drug Delivery”, Biomacromolecules 2018, 19, 2194−2201) hereinafter Wang.
Regarding claims 1-8, Wang is drawn to assembly of coumarin-anchored low generation dendrimers in aqueous solution via hydrophobic interactions. The synthesized material showed significantly improved DNA binding and gene delivery, and minimal toxicity on the transfected cells. Moreover, the coumarin moieties in the assembled nanostructures endow the materials with light-responsive drug delivery behaviors. The coumarin substitutes in the assembled nanostructures were cross-linked with each other upon irradiation at 365 nm, and the cross-linked assemblies were degraded upon further irradiation at 254 nm. As a result, the drug-loaded nanoparticle showed a light-responsive drug release behavior and light-enhanced anticancer activity (abstract).
Wang discloses anchoring of a hydrophobic coumarin moiety on the surface of a low generation dendrimer to yield an amphiphilic dendrimer for improved gene delivery. Coumarin was modified on a generation 1 (G1) polyamidoamine (PAMAM) dendrimer to construct an amphiphilic G1 dendrimer-coumarin conjugate (G1-CM) for efficient and nontoxic gene delivery. Incorporation of the photoresponsive coumarin group in the amphiphile has the advantage of being able to covalently cross-link and degrade the assembled structure by exposure to different UV light irradiations. Owing to the reversible dimerization of coumarin moieties, the assembled nanocarrier exhibited a light-responsive drug release profile and showed complementary anticancer activity when codelivering anticancer drugs and therapeutic genes (pg. 2195)
Wang discloses coumarin-anchored dendrimer G1-CM was able to assemble into nanostructures via hydrophobic interactions and exhibited much improved DNA binding, cellular uptake, and gene transfection efficacy. The assembled G1-CM was loaded with 5-Fu, and the drug-loaded nanoparticles showed light-responsive drug release and anticancer activity. In addition, G1-CM allowed the codelivery of 5-Fu and the TRAIL plasmid for combination cancer therapy. This study provided a facile strategy to develop amphiphilic polymers for efficient gene delivery and light-responsive drug delivery (pg. 2199).
Wang does not explicitly disclose each of the components of the composition together as claimed in a single embodiment for an anticipation rejection
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Wang, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Wang discloses all the required ingredients and Wang discloses anchoring of a hydrophobic coumarin moiety on the surface of a low generation dendrimer to yield an amphiphilic dendrimer for improved gene delivery (pg. 2195). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Claims 22-33 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (“Improved tumor targetability of Tat-conjugated PAMAM dendrimersas a novel nanosized anti-tumor drug carrier”, Drug Dev Ind Pharm, 2015; 41(4): 617–622) hereinafter Yan.
Regarding claims 22-33, Yan is drawn to generation 4-poly-amidoamine-dendrimers (PAMAM G4 dendrimer, P) was conjugated to Tat peptide (Tat, T), a cell-penetrating peptide, in search of an efficient anti-tumor drug delivery vehicle for cancer therapy. In this study, we synthesized BODIPY-labeled Tat-Conjugated PAMAM dendrimers (BPTs) as a novel nanosized anticancer drug carriers. The Tat-modified dendrimer, BPT(64) with appropriate particle size showed a better retention in blood and could be accumulated effectively in tumor tissue via the enhanced permeability and retention (EPR) effect. Moreover, BPTs with a high Tat modification rate was accumulated more effectively in tumor tissue. In vitro experiments, these BPTs displayed low cytotoxicity on S180 cells and high uptake to S180 cells. These findings indicate that the nanoparticulate system on the basis of Tat-conjugated PAMAM dendrimers is safer and effective in the concentration range (below20 mg/ml) to be used as a carrier of anti-tumor drugs for tumor targeting by intravenous administration (abstract).
Yan discloses poly-amidoamine (PAMAM) dendrimer is highly branched macromolecules composed of an amine surface and an ethylene-diamine core. PAMAM dendrimers with a unique class of nanostructures possess hydrophobic interior and hydrophilic exterior. The multifunctionality and biocompatibility of PAMAMG4 dendrimers are crucial as targeted drug delivery carriers for cancer treatment (pg. 617).
Yan discloses AMAM G4 dendrimer was reacted with BOPIDY in NaHCO3 solution for 12 h at 4 C. The reaction was purified on a G-25 size exclusion column to remove remaining free BODIPY derivatives. The product recovered from G-25 was dried under reduced pressure to give BODIPY-PAMAM conjugate (BP) (pg. 618). Yan discloses the mean diameter of these BPTs was much larger (about from 42.24 nm to 69.62 nm (pg. 619). Yan discloses particle size can significantly impact the biodistribution of nanoparticles. After administration, small nanoparticles with size smaller than 5.5 nm are rapidly cleared by the renal excretion, while particles 200 nm or greater in size are more efficiently taken up by the mononuclear phagocytic system, with cells in the liver, spleen and bone marrow 36,37. It has been well described that tumor blood vessels are leaky with fenestrations ranging between 0.2 and 1.2 mm; therefore, nanoparticles with size below 200 nm can take advantage of the EPR effect for enhanced drug accumulation in tumors (pg. 620).
Yan does not explicitly disclose each of the components of the composition together as claimed in a single embodiment for an anticipation rejection.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Yan, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Yan discloses all the required ingredients and Yan discloses BODIPY-PAMAM conjugate (BP) (pg. 618), and Yan discloses PAMAM dendrimers with a unique class of nanostructures possess hydrophobic interior and hydrophilic exterior. The multifunctionality and biocompatibility of PAMAMG4 dendrimers are crucial as targeted drug delivery carriers for cancer treatment (pg. 617). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615