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/Restrictions
Applicant’s election of Group I in the reply filed on 2/17/2026 is acknowledged. Because applicant 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)).
Claim 34 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/17/2026.
Allowable Subject Matter
Claims 13 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1-5 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kiefer et al. (WO2020/037206 A1) in view of Alharbi NF. (2019, Human Vaccines & Immunotherapeutics, Vol. 15(1), pgs. 203-209).
Regarding claims 1-4 and 41, Kiefer et al. teach a recombinant nucleic acid comprising a MYXV genome and first nucleic acid encoding IL-12β (a cytokine), wherein the nucleic acid encoding human IL-12β is inserted into the MYXV genome to disrupt expression of the M153 gene and driven by a poxviral early/late promoter, designated as vMyx-PD1/ΔM153/IL12. Kiefer continues to teach that nucleic acid can comprise both human IL-12α and IL-12β (see Fig. 1 reproduced below, pg. 39 lines 40-47, parag. 94 and Example 1).
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Regarding claim 5, Kiefer teaches that the human IL-12α and IL-12β can be expressed as a fusion protein with a linker sequence, thus the 5’ end of the nucleic acid encoding human IL-12α will be coupled to the 3’ end of the nucleic acid encoding IL-12β (parag. 94).
Kiefer does not teach:
Using the poxvirus P11 late promoter.
Regarding the P11 late promoter, Alharbi NF. teaches that the P11 late promoter
is a strong promoter for driving expression of transgenes to induce an immune response (pg. 204 col. 1 parag. 2 lines 1-6).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to modify the teachings of Kiefer regarding a recombinant nucleic acid comprising a MYXV genome with the teachings of Alharbi regarding the P11 late promoter to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to substitute the P11 late promoter of Alharbi for the poxviral early/late promoter of Kiefer since Alharbi teaches that the P11 late promoter is a strong promoter for driving transgenes involved in inducing an immune response.
There would have been a reasonable expectation of success that the P11 late promoter of Alharbi would work in the recombinant nucleic acid of Kiefer since Alharbi teaches that the P11 late promoter is capable of driving transgene expression.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Claim(s) 6-12 and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kiefer et al. (WO2020/037206 A1) in view of Alharbi NF. (2019, Human Vaccines & Immunotherapeutics, Vol. 15(1), pgs. 203-209) as applied to claims 1-5 and 41 above, and further in view of Huang et al. (2016, Molecular Therapy – Methods & Clinical Development, Vol. 3, pgs. 1-11) and Oh et al. (2017, Oncotarget, Vol. 8(3), pgs. 4730-4746).
Kiefer and Alharbi are relied upon above in teaching a recombinant nucleic acid comprising a MYXV genome and first nucleic acid encoding IL-12β, wherein the nucleic acid encoding human IL-12β is inserted into the MYXV genome to disrupt expression of the M153 gene and driven by a P11 late promoter.
Regarding claims 9-12, 17, 18 and the use of multiple sE/L promoters, Kiefer teaches that they can use multiple sE/L promoters in any arraignment that would facilitate expression (parags. 16, 60, 74 and claim 10, 11, 59 and 60).
Regarding claims 15 and 16, Kiefer teaches that their recombinant nucleic acid can comprise a nucleic acid encoding a reporter tag such as GFP (parag. 76).
Kiefer and Alharbi do not teach:
Using an elastin linker; and
A nucleic acid encoding human decorin.
Regarding an elastin linker in claim 6, Huang et al. teach an elastin linker is
commonly used when linking IL-12β and IL-12α (see Fig. 1A) and specifically teaches:
“the codon-optimized cDNA of human IL-12 β chain (p40) fused to the α chain (p35) by an
Elastin linker (VPGVGVPGVG),” (pg. 9 col. 2 parag. 1 lines 1-3).
Regarding a nucleic acid encoding human decorin, Oh et al. teach when IL-12 is
co-expressed with human decorin (DCN) the efficacy of IL-12 mediated cancer immunotherapy is enhanced (see Abstract).
Oh concludes by teaching that “Collectively, these results demonstrated that combining IL-12 and DCN is a promising candidate strategy to induce a potent antitumor immune response for treating highly immunosuppressive clinical tumors by overcoming Treg-mediated immunosuppression.” (pg. 4741 col. 1 parag. 2).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Kiefer and Alharbi regarding a recombinant nucleic acid comprising a MYXV genome with the teachings of Huang regarding an elastin linker and Oh regarding human decorin to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to link IL-12β and IL-12α since Huang demonstrated success linking IL-12β and IL-12α using elastin. Further motivation is provided by Oh to co-express IL-12 and human decorin since this enhances that Il-12 mediated cancer immunotherapy.
There would have been a reasonable expectation of success that IL-12β and IL-12α could be linked with elastin and that IL-12 could be co-expressed with human decorin since Huang and Oh demonstrated as such respectfully.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
Claims 13 and 14 are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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