DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-16 are included in the prosecution.
Claim Interpretation
Regarding claims 11-12, the claimed cancer therapeutic agent is drawn to product claims and therefore the intended use of the agent, “for use in …” does not carry patentable weight over the teachings of the prior art.
Claim Rejections – 35 U.S.C. 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.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Farokhzad et al. (US20190374479A1) hereinafter Farokhzad.
Regarding claims 1-16, Farokhzad is drawn to particles and compositions comprising polysaccharide selected from mannan and dextran; and methods of administering the particle in combination with an adjuvant and methods of treating cancer (abstract and claims 1-30).
Farokhzad discloses nanocapsules containing polysaccharide-based PAMPs, for example, mannan- or dextran-based PAMPs. These nanocapsules exhibit strong adjuvanticity, promoting dramatic recruitment and activation of immune cells in lymph nodes (LNs) after in vivo administration. The nanocapsules are also useful as delivery vehicles for tumor antigen-encoding messenger RNA (mRNA) to the antigen presenting cells (APCs) [0005].
Farokhzad discloses a shell comprising a crosslinked polyamine layer with a polysaccharide coating, and a biomolecule between the crosslinked layer the polysaccharide coating [0050].
Farokhzad discloses a nanocapsule, composed of mannan, carrying ovalbumin-encoding mRNA as the payload, elicits robust antigen-specific CD8+ T-cell response, leading to significant reduction in tumor burden in tumor bearing-mice [0098;0113]; molecular weight of polyethyleneimine may be between about 500 Da and about 100,000 Da [0107].
Farokhzad discloses the particles present within a population, e.g., in a composition, can have substantially the same shape and/or size. For example, the particles can have a distribution such that no more than about 5% or about 10% of the particles have a diameter greater than about 10% greater than the average diameter of the particles [0103]; the therapeutic protein is a cytokine, such as transforming growth factor-beta (TGF-beta), interferons (e.g., interferon-alpha, interferon-beta, interferon-gamma), colony stimulating factors (e.g., granulocyte colony stimulating factor (GM-CSF)), and thymic stromal lymphopoietin (TSLP) [0125]. The antibody is useful in treating cancer [0136]. The therapeutic protein is useful in treating cancer; wherein the cancer is any one of cancers described herein [0151].
Farokhzad discloses polysaccharide-coated particles (e.g., nanocapsules), upon contact with the antigen-presenting cell and upon binding to a pattern recognition receptor (PRR), activate molecular pathways leading to immunogenic response by the antigen-presenting cell. Suitable examples of PRR include CD209 [0186]
Farokhzad discloses the particles are useful, therefore, for vaccinating the subject against the pathogens containing the antigen. For example, if the antigen protein is a cancer-specific antigen, the particles are useful as a vaccine against cancer. Alternatively, the particle may comprise a protein that is a pathogen/disease-specific antigen. In this case, the APS need not transfect and/or express the protein. The APS initiates the molecular mechanisms to present the antigen to the immune system cells for the antibody generation [0186].
Farokhzad discloses upon local (e.g., intra-tumor) administration of the particle to the patient, the particle induces an inflammatory response by the innate immune cells, such as DCs and macrophages. The particles, therefore, can substantially potentiate the cancer therapy [0190]. The particles and biomolecules disclosed herein are useful for modulating (e.g., stimulating or enhancing) an immune response, and therefore a useful for treating cancer, for example, by administering to a subject an amount of the particle or the biomolecule that is effective to stimulate T cells in the subject having cancer [0194].
Farokhzad discloses the particles and compositions can be administered to a subject (e.g., in need of the administration of the particle) alone or in combination with one or more additional therapeutic agents [0210]. the particle of the present disclosure, or a composition comprising same, can be administered in combination with and adjuvant [0212].
Farokhzad does not explicitly disclose each of the components of the composition in a single embodiment.
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 Farokhzad, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Farokhzad discloses all the required components and discloses a nanocapsule, composed of mannan, carrying ovalbumin-encoding mRNA as the payload, elicits robust antigen-specific CD8+ T-cell response, leading to significant reduction in tumor burden in tumor bearing-mice [0098;0113]; Farokhzad discloses polysaccharide-coated particles (e.g., nanocapsules), upon contact with the antigen-presenting cell and upon binding to a pattern recognition receptor (PRR), activate molecular pathways leading to immunogenic response by the antigen-presenting cell. Suitable examples of PRR include CD209 [0186]. 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