DETAILED ACTION
Applicant’s election without traverse of the species the TLR agonists TLR7/8 in the reply filed on 7/6/2026 is acknowledged.
Claims 2-9 and 12, 18, 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/6/2026.
Accordingly, Claims 1, 10, 11, 13-17 and 20-21 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 § 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 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, 10, 11, 13-17 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bi et al. (Int J Immunol.,Vol. 38, No. 4, 31 July 2015) in view of Avery et al. (J Immunol 2008; 181:1767-1779).
The claims are drawn to a method for producing an antibody or antigen-binding fragment thereof comprising cultivating PBMCs in a medium comprising a TLR agonist (TLR7/8) and further comprises cytokines IL-2 and IL-21. The claims are further drawn to isolating the nucleic acid from the produced antibody secreted from the PBMCs and introducing said nucleic acid into a host cell for expression of said antibodies.
Bi et al. teach methods for activation and differentiation of memory B cells into PBMCs to isolate antigen specific antibody secreting cells for development of antibody drugs. Bi et al. disclose “activated dendritic cells, T cells, and B cells” have been previously used to induce production of antigen-specific antibodies (cited reference #10 by Bi et al.). Bi et al. teach PMBCs were isolated from peripheral blood of two healthy donors and induced by adding cytokines (IL-2 and IL4) and TLR activators for 6 days. Bi et al. found IgG concentrations treated with both anti-CD40 antibody and IL-2 and the TLR7/TLR8 agonist “R848” combined with IL-2 were higher than that in the control group. Section 1.3.2 of Bi et al. disclose IL-2 concentrations at 100ng/mL and CD40 concentrations 2ug/mL. Bi et al. teach a successful method to induce activation and differentiation of memory B cells from PMBCs into antigen-specific plasma cells. Bi et al. discloses the objective of isolating the antibodies for development of antibody drugs. Bi et al. does not teach adding cytokine IL-21, this deficiency is made up for by Avery et al.
Avery et al. teaches IL-21 induces isotype switching to IgG of human naïve b cells. Avery et al. uses B cells from peripheral blood and umbilical cord blood. Avery et al. teach IL-21 individually induced CD40L-stimulated human naïve B cells to undergo switching to IgG. Avery et al. also discloses IL-4 and IL-21 induce isotype switching in CD40L-stimulated human naïve B cells to IgG at a comparable rate and that the combination of these cytokines has a synergistic outcome on this event. Avery et al. discloses “switching to downstream isotypes, therefore, provides versatility in both Ig function and distribution, without altering antigenic specificity, since the Ig variable region remains unchanged during this process.”
I would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce an antibody comprising culturing PBMCs in a medium comprising CD40L, a TLR agonist, IL-2, and IL-21 as well as isolate the nucleic acids for expression in a host cell to produce the antibodies for therapeutic purposes as taught by Bi et al. and Avery et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success based on both Bi et al. and Avery et al., which teach methods of enhancing antibody production by PBMCs by the addition of various cytokines such as IL-2, IL-21 and IL-4 which are shown to act synergistically and to make a more versatile therapeutic antibody.
Conclusion
Claims 1, 10, 11, 13-17 and 20-21 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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