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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). Acknowledgment is made of Applicants’ claim for benefit to foreign application GB2013466.4 filed 08/27/2020.
This application claims the benefit of priority to Patent Application PCT/PT2021/050028. Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application
Number PCT/PT2021/050028, filed on 08/25/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 02/27/2023 and 05/05/2023 have been considered by the Examiner.
Status of Claims
Claims 1-4, 6-9, 11, 13-20, 22-23, and 27 are under examination.
Claims 5, 10, 12, 21, and 24-26 are cancelled.
Claim Objections
Claims 9, 11, 13-16, 18-19, 22-23, and 27 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 § 112
Rejection to claims 13-16 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inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, have been withdrawn in view of the applicant’s amendment filed 12/24/2025.
Claim Rejections - 35 USC § 102
Rejection to claims 1-4, 7, 9, 11, 18, 20, 22-23, and 27 under 35 U.S.C. 102(a)(1) as being anticipated by Gruenert (WO 2020/091958 A1) has been withdrawn in view of applicant’s amendments filed 12/24/2025.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Rejections maintained:
Claims 1-4, 6-8, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamata et al. (PLoS ONE, 2010).
Regarding claim 1, Kamata et al. teach a genetic construct comprising: (i) a ubiquitin C promoter (a constitutive promoter) operably linked to a nucleic acid sequence encoding mCherry, a reporter molecule where the construct further includes microRNA target sites miR-223, miR-155, and miR-142-3p; and (ii) a second promoter (CMV-constitutive promoter) operably linked to EGFP and an inhibitor of the first promoter which includes miR-302a/d targets which are different than the first targets (page 2, Figure 1A).
Regarding claim 2, Kamata et al. teach a genetic construct as described above in regards to claim 1. Kamata et al. further teach the miRNA target site of the second nucleic acid are miR-302a/d targets. Kamata et al. teach the second target sites are different targets than miR-223, miR-155, and miR-142-3p the target sites of the first nucleic acid sequence (page 3, Characterization of a miRNA dependent reporter vector that distinguishes pluripotent cells from differentiated progeny).
Regarding claim 3, Kamata et al. teach a genetic construct as described above in regards to claim 1. Kamata et al. teach the construct includes 3 miRNA target sites which include a copies of miR-223, miR-155, miR-142-3p within the first nucleic acid sequence (page 3, Characterization of a miRNA dependent reporter vector that distinguishes pluripotent cells from differentiated progeny).
Regarding claim 4, Kamata et al. teach a genetic construct as described above in regards to claim 1. Kamata et al. teach the miRNA target sites present in the first nucleic acid are miR-223, miR-142-3p, and miR-155. Kamata et al. further teach miR-223, miR-142-3p, and miR-155 are enriched primarily in cells of hematopoietic origin (page 8, right column).
Regarding claim 6, Kamata et al. teach a genetic construct as described above in regards to claim 1. Kamata et al. teach the second nucleic acid includes 2 miRNA target sites which includes copies of miR-302a and miR-302d (miR-302 a/d) (page 3, Characterization of a miRNA dependent reporter vector that distinguishes pluripotent cells from differentiated progeny).
Regarding claim 7, Kamata et al. teach a genetic construct as described above in regards to claim 1. Kamata et al. teach the miR-302a and miR-302d target sites. Kamata et al. further teach miR-302 gene encodes a cluster of eight miRNAs which are preferentially expressed in embryonal carcinoma cells, which reads on diseased cell (page 9, Construction of lentiviral vector).
Regarding claim 8, Kamata et al. teach a genetic construct as described above in regards to claim 1. Kamata et al. teach the construct includes GFP and mCherry which are optical reporters (page 9, Construction of lentiviral vector).
Regarding claim 17, Kamata et al. teach a genetic construct as described above in regards to claim 1. Kamata et al. further teach the second promoter is arranged in the opposite orientation in the construct to the first promoter (pages 2&3, Characterization of a miRNA dependent reporter vector that distinguishes pluripotent cells from differentiated progeny & Figure 1A).
Regarding claim 20, Kamata et al. teach a lentiviral vector encoding EGFP miR-T/mCherry miR-T (page 3, Figure 1A legend). The lentiviral vector taught by Kamata et al. reads on a recombinant vector.
Response to Argument
Applicant’s arguments, see page 7, filed 12/24/2025, with respect to claims 1-4, 7, 9, 11, 18, 20, 22-23, and 27 over Gruenert (WO 2020/091958 A1) have been fully considered and are persuasive. The rejections to the claims have been withdrawn.
Applicant's arguments filed 12/24/2025 with regard to Kamata et al. have been fully considered but they are not persuasive.
Applicant’s arguments: Applicant argues Kamata et al. does not disclose a vector encoding an inhibitor of the first promoter or therapeutically active/reporter molecule, as claimed. Applicant argues Kamata et al. teaches a vector system for monitoring hiPSC formation and subsequent differentiation from human fetal fibroblasts (HFFs). Kamata does not relate to a system for identifying diseased cells, and regulating the expression of a therapeutic gene into the diseased cells. Applicant argues the skilled person looking to develop an improved genetic construct for identifying diseased cells and regulating the expression of a therapeutic gene into the diseased cells, would not have considered looking at the teachings of Kamata.
Examiner’s response: The limitations of the claim require a first nucleic acid sequence encoding a therapeutically active molecule or a reporter molecule. Kamata et al. teach a genetic construct comprising: promoter operably linked to a nucleic acid sequence encoding mCherry. Kamata et al. teach a second promoter operably linked to EGFP and an inhibitor of the first promoter which includes miR-302a/d targets which are different than the first targets (page 2, Figure 1A).
Kamata et al. does not specifically teach utilization for recognizing and regulating the expression in diseased cells, however the vector is used for cell identification. Kamata et al. teach all of the claimed limitations of the present application. Kamata et al. further teach miR-302 gene encodes a cluster of eight miRNAs which are preferentially expressed in embryonal carcinoma cells, which reads on diseased cell (page 9, Construction of lentiviral vector).
Claim Rejections - 35 USC § 103
Rejection to claim 13 under 35 U.S.C. 103 as being unpatentable over Gruenert (WO2020/091958 A1) as applied to claims 1 and 11 above, and further in view of Um et al. (WO 2016/108333 Al) has been withdrawn in view of applicant’s amendments filed 12/24/2025.
Rejection to claim 14 under 35 U.S.C. 103 as being unpatentable over Gruenert (WO2020/091958 A1) as applied to claims 1 and 11 above, and further in view of Wang et al. (CN108676097-A) has been withdrawn in view of applicant’s amendments filed 12/24/2025.
Rejection to claim 15 under 35 U.S.C. 103 as being unpatentable over Gruenert (WO2020/091958 A1) as applied to claims 1 and 11 above, and further in view of Hochberg et al. (WO 03/035883 A2) has been withdrawn in view of applicant’s amendments filed 12/24/2025.
Rejection to claim 16 under 35 U.S.C. 103 as being unpatentable over Gruenert (WO2020/091958 A1) as applied to claims 1 and 11 above, and further in view of Bonny et al. (EP1661912) has been withdrawn in view of applicant’s amendments filed 12/24/2025.
Rejection to claim 19 under 35 U.S.C. 103 as being unpatentable over Gruenert (WO2020/091958 A1) as applied to claim 1, and further in view of Yan et al. (CN104017827-A) has been withdrawn in view of applicant’s amendments filed 12/24/2025.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
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