DETAILED ACTION
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 .
Applicant’s election of Group I, claims 1-6, 8, 13, 14,16, 45-47, 63, 64, 72 and 73 in the reply filed on 07/29/2026 is acknowledged. Because applicants 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)).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/10/2024, 06/28/2024, 12/02/2024, 01/03/2025, 04/04/2025, 07/09/2025 and 02/09/2026 was noted and the submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 01/08/2024. These drawings are acknowledged.
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.
Claim(s) 1, 2, 45, 46 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Charles H. Reynolds et al., (J. Am. Chem. Soc, 122, 8940-8945, 2000).
Reynolds discloses gadolinium-loaded polymeric nanoparticles that have potential as contrast agents for medical imaging. The polymeric materials have a core-shell morphology, the interior is a functionalized polymer, that provides high affinity for a specific metal, and the shell consists of a porous hydrophobic polymer that modulates access to the core. The nanoparticles are loaded with Gd3+ to provide contrast in magnet resonance (MR) imaging (abstract). The spherical metal-loaded core-shell nanoparticles have an average diameter of 120 nm. The size and composition of the nanoparticles provide favorable pharmacokinetic properties, including limited biodistribution and bioavailability (page 8941 and Figure 1). Additional disclosure includes that the shell allows efficient water exchange, and in vitro and vivo testing demonstrated the effectiveness of nanoparticles as oral and IV contrast agents.
Claim(s) 1, 2, 45, 46 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uvdal et al. (WO 2006/031190).
Uvdal discloses superparamagnetic gadolinium oxide nanoparticles and their utility in selective tissue imaging as well as magnetic resonance imaging associated techniques (abstract). The particles preferably have a biocompatible and/or biospecific coating. Suitable coating includes diethylene glycol (DEG), polyethylene glycol (PEG) (page 4 line 25-35). The superparamagnetic comprises rare earth metal oxide having average sizes below 50 nm and include oxides of gadolinium and dysprosium (page 8-12). Additional disclosure includes that the coatings serve to counteract agglomeration of the particles to larger units and consequential loss of superparamagnetism, to render the particles compatible in a selected biological environment, and/or to enable the introduction of a certain biospecifity.
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.
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.
Claim(s) 1-6, 8, 13, 14, 16, 45-47, 63, 64, 72 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Charles H. Reynolds et al., (J. Am. Chem. Soc, 122, 8940-8945, 2000) in view of Pucci et al, (US 2020/0131239) and Springer et al. (US 7,354,588).
Reynolds discloses gadolinium-loaded polymeric nanoparticles that have potential as contrast agents for medical imaging. The polymeric materials have a core-shell morphology, the interior is a functionalized polymer, that provides high affinity for a specific metal, and the shell consists of a porous hydrophobic polymer that modulates access to the core. The nanoparticles are loaded with Gd3+ to provide contrast in magnet resonance (MR) imaging (abstract). The spherical metal-loaded core-shell nanoparticles have an average diameter of 120 nm. The size and composition of the nanoparticles provide favorable pharmacokinetic properties, including limited biodistribution and bioavailability (page 8941 and Figure 1). Additional disclosure includes that the shell allows efficient water exchange, and in vitro and vivo testing demonstrated the effectiveness of nanoparticles as oral and IV contrast agents.
Reynolds fails to disclose binding agents in the composition.
Pucci discloses composition comprising a nucleated cell and a nanoparticle that comprises at least one conservation agent nucleated cell-nanoparticle complex) (0007). The conservation agent comprises a cytokine molecule or a costimulatory molecule, and the cytokine molecule is chosen from IL15, IL2, IL6, IL7, IL12, IL17, IL18, IL21, IL-23, IL-4, IL1alpha, IL1beta, IL-5, IFNgamma, TNFa, IFNalpha, IFNbeta, GM-CSF, or GCSF (reads on priming agent) (0013-0015). In embodiments, the nanoparticle is covalently conjugated, e.g., to the surface, of the nucleated cell (0044). In some embodiments, the nanoparticle is a protein nanogel formed by a plurality of conservation agents covalently linked to each other, the nanoparticle comprises at least one polymer, cationic polymer, or cationic block co-polymer on the nanoparticle surface. In embodiments, the nanoparticle comprises polyethylene glycol (PEG) (0045 and 0408). In embodiments, the nanoparticle comprises an antibody molecule to CD45, CD11a (integrin alpha-L), CD18 (integrin beta-2), CD11b, CD11c, CD25, CD8, or CD4 (0068). In some embodiments, the nanoparticle comprises an entity that binds a protein, e.g., a receptor, present on an NK cell and the entity may be an agonist ligand or an agonist antibody molecule. In embodiments, the stimulatory receptor is TRAIL, CD16, NKp30a,b, (0069-0070). In embodiments, said conservation agent is chosen from one or more (e.g., 2, 3, 4, 5 or more) therapeutic or biologically active proteins, e.g., one or more cytokine molecules (e.g., IL-15), thus, the compositions can provide a significant benefit for cellular therapy, e.g., immunotherapy (0257).
Spinger discloses a pharmaceutical composition comprising a functional derivative of ICAM-1 in admixture with a pharmaceutically acceptable carrier (claim 8). Springer discloses that the antibody and ICAM-1 molecules can be formulated according to known methods to prepare pharmaceutically useful compositions suitable for effective administration, and compositions will contain an effective amount of anti-ICAM antibody or ICAM-1 molecule, or their functional derivatives, together with a suitable amount of carrier vehicle (Col. 25 line 3-15). Additional disclosure includes pharmaceutical methods that may be employed to control the duration of action by controlled release preparations is to incorporate anti-ICAM-1 antibody or ICAM-1 molecules, or their functional derivatives, into particles of a polymeric material such as polyesters, polyamino acids, hydrogels, poly(lactic acid) or ethylene vinylacetate copolymers (Col. 25 line 17-35).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate various binding agents as taught by Pucci into Reynolds’s composition. The person of ordinary skill in the art would have been motivated to make those modifications because Pucci teaches that the nanoparticle-treated nucleated cells can show a significantly increased function, e.g., one or more of viability, proliferation, cytotoxic activity or activation, after a freeze-thawing cycle, compared to untreated nucleated cells and thus, compositions can provide a significant benefit for cellular therapy, e.g., immunotherapy (0006) and reasonably would have expected success because cells (e.g., thawed cells) treated with the compositions taught by Pucci have tumor infiltration activity, e.g., when a tumor is excised and expanded donor cells are counted by flow cytometry, e.g., in an assay of Example 36, the cells treated with the composition result in at least 200, 400, 600, or 800 cells/mg tumor, the cells treated with the composition result in greater tumor infiltration levels, e.g., by at least 1-fold, 2-fold, 3-fold, 4-fold, or 5-fold, compared to otherwise similar cells not treated with the composition (0085).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate ICAM-1 binding antibody as taught by Pucci into Reynolds’s composition. The person of ordinary skill in the art would have been motivated to make those modifications because Springer teaches that since ICAM-1 is expressed mostly at sites of inflammation, monoclonal antibodies (antibodies detectably labeled through the use of radioisotopes, fluorescent labels, paramagnetic atoms) capable of binding to ICAM-1 may be employed as a means of imaging or visualizing the sites of infection and inflammation in a patient (Col. 22 line 4-8) and reasonably would have expected success because ICAM-1 is a binding partner of LFA-1 and may be employed interchangeably with antibodies capable of binding to LFA-1 in the treatment of disease, such as to block the metastasis or proliferation of tumor cells which express either ICAM-1 or LFA-1 on their surfaces.
Conclusion
No claims are allowed at this time.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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