DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I and species “IL2” and “systemic lupus erythematosus” in the reply filed on 3/4/2026 is acknowledged.
Claims 7, 13, 14, 24, 26-29, 41, 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/4/2026.
Claims 1, 3-6, 8-12, 15-21, 23, 25, 30-40, 43-47 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Claims 1, 3-6, 8-12, 15-21, 23, 25, 30-35, 37, 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horwitz et al. (Arthritis & Rheumatology, Vol. 71, No. 4, March 2019, pages 632-640, cited on IDS filed 8/16/2023).
The claims are drawn to a method of treating systemic lupus erythematosus comprising administering an artificial Antigen Presenting Cell (aAPC) composition comprising (i) at least one synthetic polymeric nanoparticle, (ii) at least one targeting agent (anti-CD2), and (iii) at least one stimulating agent (encapsulated IL2) for inducing NK cells to become TGF-β producing regulatory NK cells, wherein both CD4 and CD8 cells are induced to become Foxp3+ T regulatory cells.
Horwitz et al. teach a tolerogenic artificial APC composition comprising anti-CD2/CD4 antibody-loaded PLGA nanoparticles encapsulating IL-2 and TGF-β that induced CD4+ an dCD8+ FoxP3+ Treg cells in a DBA/2 mouse systemic lupus erythematosus (SLE) model. Horwitz et al. teach that nanoparticles containing IL-2 and TGF-β targeted to T cells induce large numbers of CD4+ and CD8+ Tregs in vivo that protect BDF1 mice from lupus-like disease. The aAPC and methodology taught by Horowitz is analogous to that used in the instant claims and would therefore inherently induce NK cells in a subject to become TGF-β producing regulatory T cells.
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.
Claims 1, 3-6, 8-12, 15-21, 23, 25, 30-40, 43-47 are rejected under 35 U.S.C. 103 as being unpatentable over Horwitz et al. (Arthritis & Rheumatology, Vol. 71, No. 4, March 2019, pgs 632-640, cited on IDS filed 8/16/2023) in view of Selsted et al. (WO2012/167077).
The claims are drawn to a method of treating systemic lupus erythematosus comprising administering an artificial Antigen Presenting Cell (aAPC) composition comprising (i) at least one synthetic polymeric nanoparticle, (ii) at least one targeting agent (anti-CD2), and (iii) at least one stimulating agent (encapsulated IL2) for inducing NK cells to become TGF-β producing regulatory NK cells, wherein both CD4 and CD8 cells are induced to become Foxp3+ T regulatory cells. The claims are further drawn to comprising at least one anti-inflammatory agent, a defensin.
The teachings of Horwitz et al. are presented in the 102(a)(1) rejection set forth above. Horwitz et al. does not teach an aAPC comprising an additional anti-inflammatory agent, defensin. This deficiency is made up for by Selsted et al.
Selsted et al. teach drug compositions for treatment of one or more inflammatory conditions comprising administering at least one of a theta-defensin (RTD-1), a naturally occurring cyclic peptide expressed in tissues of rhesus monkeys. Selsted et al. disclose, preferably, the compositions are administered orally, subcutaneously, intraperitoneally, or intravenously. The cyclic peptides can be used as therapeutics across a variety of disease states or conditions, such as autoimmune and other inflammatory diseases, that result from dysfunctional cytokine activity, and a variety of inflammatory diseases and/or conditions in humans including lupus.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer an aAPC nanoparticle composition as taught by Horwitz et al. further comprising the anti-inflammatory defensin RTD-1 as taught by Selsted et al. to the same inflammatory patient population with dysfunctional cytokine activity for improved therapeutic benefit. Furthermore, the claimed routes of administration including intravenous, intramuscular, subcutaneous, and orally are well known routes of administration as taught by Selsted et al. and would be obvious to administer the aAPC nanoparticles taught by Horwitz et al. via the same routes and is well within the purview of one of ordinary skill in the art at the time the invention was made.
Conclusion
Claims 1, 3-6, 8-12, 15-21, 23, 25, 30-40, 43-47 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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