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 .
RESPONSE TO AMENDMENT
The amendment, response and certified translation of the priority document filed 5-11-2026 has been entered into the record. Claims 2-4 have been cancelled. Claims 1 and 5-12 are pending. Claims 1 and 5-7 are under examination. Claims 8-12 remain withdrawn from consideration.
The text of Title 35 of the U.S. Code not reiterated herein can be found in the previous office action.
Priority
The Office acknowledges the filing of a certified translation of the foreign priority document. The priority date for the claimed invention is the foreign priority date of 3-22-2021.
Objection/Rejections Withdrawn
The objection to claim 3 because of the following informalities is withdrawn in view of the cancelation of the claim.
The rejection of claims 3 and 4 under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in view of the cancelation of the claims.
The rejection of claims 1-7 under 35 U.S.C. 102(a)(1) as being anticipated by Jeong et al (Journal for ImmunoTherapy of Cancer 9:e003180, pages 1-14, 13 August 2021; of record on PTOL-1449) is withdrawn in view of the English language translation of the Korean priority document filed in accordance with MPEP §§ 215 and 216.
The rejection of claims 1-7 under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al (PLOS One, 10(3):e0122897, pages 1-21, March 30, 2015; of record on PTOL-1449) is withdrawn in view of the amendment to the independent claim.
The rejection of claims 1-7 under 35 U.S.C. 103 as being unpatentable over Lee et al (PLOS One, 10(3):e0122897, pages 1-21, March 30, 2015; of record on PTOL-1449) in view of Mo et al (Infection and Immunity, 75(10):4804-4816, 2007) is withdrawn in view of the amendment to claim 1.
Rejections Maintained
The rejection of claims 1 and 57 under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendment of claim 1 and cancelation of dependent claims is maintained for reasons set forth in the Office Action for claims 1-7, mailed 2-10-2026.
Applicant’s amendment does not address the issue with respect to sequence variants encompassed by the terms “MIF” and IL-7” as set forth in paragraph [0018] of the specification. As such, the claims remain rejected.
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (PLOS One, 10(3):e0122897, pages 1-21, March 30, 2015; of record on PTOL-1449) in view of Sahin et al (WO 2019/154985, August 2019; of record) and Bloom et al (US 5,504,005; of record on PTOL-1449) for reasons made of record reasons set forth in the Office Action for claims 1-7, mailed 2-10-2026 in the alternate reasoning as reiterated below.
Lee et al teach hMIF in the pMyong2 replicable plasmid vector expressing hMIF gene under the mycobacterial hsp65 promoter (see abstract, page 4, paragraph 1, page 5, paragraph 5 to page 6 paragraph 1, Table 1 and page 10, Figure 2.D.). This is the same vector described in the specification as pMyong2-TOPO phsp65 human MIF (see Figure 5) Lee et al teach the plasmid vector is introduced in the M. smegmatis (see page 3, paragraph 2). SEQ ID NOS:1 and 2 are inherent therein to the MIF containing plasmid (Table 1, last entry). The remaining pMyong2 linear sequence is contained in GenBank Accession number JQ657806 which comprises the full sequence of pMyong2 linear plasmid. Human MIF was cloned into the pMyong2-TOPO vector (see page 4, Table 1) and was expressed in M. smegmatis (see page 16, paragraph 4). Lee et al teach that the plasmid system can be used for in vivo delivery of recombinant protein and DNA (see abstract). Lee et al differ by not expressing IL-7 from the replicable plasmid.
Sahin et al teach that the expression of RNA encoding IL-7 provides for tumor and antigen specific therapy in vivo (see Abstract and Examples).
Bloom et al teach recombinant mycobacterial vaccines expressing IL-7 (claims 4-11) wherein the IL-7 is expressed in M. smegmatis, M bovis BCG, M avium, M. phlei, M fortuitum, M lufu, M.partuberculosis, M habana, M scrofulaceum, and M intracellulare (see claim 5).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the pMyong2 replicable plasmid vector expressing hMIF gene under the mycobacterial hsp65 promoter by swapping the IL-7gene of Sahin et al for the HMIF gene in the replicable plasmid and transform any one of the Mycobacterial species of Bloom et al with the modified replicable plasmid because Sahin et al that IL-7 enhances vaccine immunity when expressed in vivo, Bloom et al teach that IL-7 is useful in a recombinant mycobacterial vaccine vehicle and Lee et al teach that the plasmid is could be effectively used to the in vivo delivery/expression of genes in vivo as a vaccine vector.
Alternatively, it would have been prima facie obvious to one having ordinary skill in the art at the time of filing to modify the pMyong2 replicable plasmid vector expressing hMIF gene under the mycobacterial hsp65 promoter by additionally including the IL-7 gene of Sanin et al and or Bloom et al because Sahin et al teach that IL-7 provides for enhanced vaccine/tumor response in vivo, Bloom et al teach that IL-7 is useful in a mycobacterial vaccine vector and Lee et al teach the advantage of high copy number and expression in the pMyong2-TOPO plasmid system in a mycobacteria.
Response to Applicant’s Arguments
Applicant’s arguments have been carefully considered but are not persuasive. Applicant argue the synergistic activities of rSmeg-pMyong2-hMIF::hIL7 as compared to expression of either alone , This is not persuasive as the claims are not limited to expression of the particular fusion protein from the pMyong plasmid and the evidence of record does not demonstrate that independent expression from the same plasmid as a non-fusion provides for the same enhanced activity as compared to the fusion. As such, the evidence is not commensurate in scope with the claims, and this is therefore not persuasive to remove the rejection of record.
New Rejections Based on Amendment
Claims 1 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (PLOS One, 10(3):e0122897, pages 1-21, March 30, 2015; of record on PTOL-1449), Sahin et al (WO 2019/154985, August 2019; of record) and Bloom et al (US 5,504,005; of record on PTOL-1449) for claims 1-7 as maintained above and further in view of Mo et al (Infection and Immunity, 75(10):4804-4816, 2007).
The combination of Lee et al (PLOS One, 10(3):e0122897, pages 1-21, March 30, 2015; of record on PTOL-1449), Sahin et al (WO 2019/154985, August 2019; of record) and Bloom et al (US 5,504,005; of record on PTOL-1449) is set forth in the Office Action for claims 1-7 reiterated above. The combination differs by not teaching the use of the hsp60 promoter.
Mo et al teach that proteins may be expressed in M. smegmatis using the hsp60 promoter (see page 4814, column 1, last paragraph).
It would have been prima facie obvious to one having ordinary skill in the art at the time of filing to modify the mycoplasma-derived replicable vector as combined for Lee et al, Sahin et al and Bloom et al and host cell comprising to further modify the pMyong2 replicable plasmid vector comprising the hMIF and IL-7 genes by swapping the hsp60 promoter of Mo et al for the hsp65 promoter in the replicable plasmid and transform M. smegmatis with the further modified replicable plasmid because Mo et al teach that the hsp60 promoter was sufficient to drive expression in M. smegmatis and the substitution of one functional equivalent for another is prima facie obvious.
Status of Claims
Claims 1 and 5-7 stand rejected. Claims 8-12 remain withdrawn from consideration.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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