NOTE: The examiner for this application has changed. The new examiner is Sean Aeder.
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 .
Election/Restriction
The response filed on 1/7/26 to the restriction requirement of 11/7/25 has been received. Applicant has elected Group I and the following species:
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Because Applicant did not distinctly and specifically point out any errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.03(a)).
Claims 1-24, 26-32, and 35 are pending.
Claims 26-32, and 35 are withdrawn from further consideration by the examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1-24 are currently under consideration.
It is noted the following species of IL-12B variants are free of the prior art: SEQ ID NOs: 77, 79, 89, and 91. The following species of IL-12B has been rejoined: SEQ ID NO:74.
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 18 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites “…wherein the additionally bound antigen binding site that specifically binds to FAP is….” There is insufficient antecedent basis for “the additionally bound antigen binding site that specifically binds to FAP” in the claim.
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 1-8, 11-21, 23, and 24 are rejected under 35 U.S.C. 103(a) as being unpatentable over Ast et al (US 2012/0276125 A1; 11/1/2012; 3/14/24 IDS).
Figure 1, Figure 2A, and Figure 2B of Ast et al teaches antigen-specific immunoconjugates for delivering an effector moiety with the following fusion protein comprising an IgG structure comprising N-terminal Fab binding domains and an effector moiety that is a cytokine attached via a linker to the C-terminus of one more heavy chain of the Fc domain:
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Ast et al further teaches said immunoconjugates wherein the cytokine is selected from a group comprising IL-12 ([0019], in particular). Ast et al further teaches said immunoconjugates wherein the IL-12 is SEQ ID NO:4 ([0191], in particular), which is identical to instant SEQ ID NO:73. Instant SEQ ID NO:73 comprises IL-12B---(G4S)3 linker---IL-12A where IL-12A is instant SEQ ID NO:75. Further, instant SEQ ID NO:73 comprises instant SEQ ID NO:74. Ast et al further teaches said IL-12 can elicit proliferation of NK cells, differentiation in an NK cell, proliferation in a T cell and differentiation in a T cell ([0191], in particular). Ast et al further teaches said immunoconjugates wherein the antigen binding domains bind Fibroblast Activation Protein (FAP; same as “fibroblast activation protein alpha”) on tumor cells ([0018] and [0204], in particular). Ast et al further teaches said immunoconjugates wherein the Fc domain is derived from human IgG1 ([0154], in particular). Ast et al further teaches said immunoconjugates wherein one of the two subunits of the Fc domain comprises a knob and the other comprises a hole ([0011], in particular). Ast et al further teaches said immunoconjugates wherein he effector moiety is fused to the amino- or carboxy-terminal amino acid of the subunit of the Fc domain comprising the knob modification ([0011], in particular). Ast et al further teaches said immunoconjugates and a pharmaceutically acceptable carrier ([0022], in particular).
Ast et al did not specifically demonstrate generating an immunoconjugate comprising an IL-12 effector moiety, wherein the immunoconjugate targets FAP. However, one ordinary skill in the art would have been motivated, with a reasonable expectation of success, to generate any immunoconjugate of Ast et al comprising any IL-12 effector moiety of Ast et al (including SEQ ID NO:4) wherein the immunoconjugate targets FAP, comprises any immunoconjugate structure of Figures 1-2 of Ast et al, and comprises Fc domains with knobs-and-holes as taught by Ast et al to promote proper heterodimerization because Ast et al teaches immunoconjugates are to target FAP on tumor cells and ([0018] and [0204], in particular) and the IL-12 effector moiety of Ast et al is taught to provide therapeutic benefits of eliciting proliferation of NK cells, differentiation in an NK cell, proliferation in a T cell and differentiation in a T cell ([0191], in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ast et al (US 2012/0276125 A1; 11/1/2012; 3/14/24 IDS) as applied to claim 1-8, 11-21, 23, and 24 above, and further in view of Park et al (US 2002/0052480 A1; 5/2/02; 11/20/25 IDS).
Teachings of Ast et al are described above.
Ast et al does not specifically teach antibody binding domains that bind FAP comprising heavy chains comprising instant SEQ ID NOs: 96-98 and 102 and light chains comprising instant SEQ ID NOs: 99-101 and 103. However, these deficiencies are made up in the teachings of Park et al.
At [0050], Park et al teaches an antibody that specifically targets FAP with a heavy chain consisting of SEQ ID NO:12 (which is identical to instant SEQ ID NO:102 and comprises instant SEQ ID NOs:96-98 and a heavy chain consisting of SEQ ID NO:2 (which is identical to instant SEQ ID NO:103 and comprises instant SEQ ID NOs: 99-101).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to generate the immunoconjugates of Ast et al wherein the light chain and heavy chain sequences of the FAP binding domains comprise just any combination of anti-FAP light chains and heavy chains of Park et al (including the combination of SEQ ID NOs: 12 and 102) because the immunoconjugates are to target FAP via Fab binding domains of the immunoconjugates that comprise heavy and light chain sequences and the heavy and light chain sequences of Park specifically target FAP. This is an example of a simple substitution of one known element for another to obtain predictable results See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642