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 .
Status of Claims
Claims 5, 14-15, and 17-19 are pending and under examination.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 102
Claims 5, 14 and 17 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Handler et al (Handler et al., Proc. Natl. Acad. Sci. USA, Volume 95, 7520-7525, 1998, Hereinafter "Handler", See PTO-892 of 04/21/2025) as evidenced by Cary (See PTO-892 of 9/19/2024).
The rejection is withdrawn in response to the amendments.
Claim Rejections - 35 USC § 103
Claims 15, and 18-19 were rejected under 35 U.S.C. 103 as being unpatentable over Handler et al (Handler et al., Proc. Natl. Acad. Sci. USA, Volume 95, 7520-7525, 1998, Hereinafter "Handler", See PTO-892 of 04/21/2025) in view of U.S.P.N. 9840718 (See PTO-892 of 9/19/2024).
The rejection is withdrawn in response to the amendments.
NEW REJECTIONS NECESSITATED BY AMENDMENTS
Claim Rejections - 35 USC § 102
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.
Claims 5, 14-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 9,840,718 (hereinafter ‘718 Patent; published Jun 2016; See PTO-892 of 09/19/2024) as evidenced by Cary (See PTO-892 of 9/19/2024).
Figure 1 of ‘718 patent shows the sequence of a plasmid 137 (as required by claims 17 and 19) comprising transposase driven by its native promoter (1-328 ntd). (See ‘781 patent col. 27, lines 49-51). Further, col. 28, lines 12-15 state that the plasmid was transfected into HEK-293 cells (mammalian – Eukaryotic cells). Col. 28, lines 42-43 indicate transposition of transgene, indicating function (transcription and translation) of the transposase (as required by claim 14). As such all elements of claim 5, 14 and 17 are anticipated. As such it is submitted that the ‘718 patent taught a method of expressing a transgene using promoter comprising instant SEQ ID NO: 1. It is also noted that piggybac transposase reads on the claimed transgene.
Regarding claim 15: It is noted that the claimed promoter was upstream of the transgene (5’ end of the transgene), in 137 plasmid as claimed. Further col. 40, lines 30-40 of ‘718 patent taught discloses that the enumerated vectors and nucleic acid constructs can be used to modulate differentiation towards a cell fate. Further col. 21, lines 55-60 of ‘718 patent disclose that the gene transfer can be used to insert nucleic acid encoding growth hormones can be introduced into target cells to promote growth in transgenic animal. These uses read on gene therapy.
Regarding claim 19: instant specification describes trans-kingdom gene therapy as transferring therapeutic material, in the form of nucleic acids and proteins, to mammalian cells by using cells belonging to different Kingdoms (for example bacteria and fungi). Col. 23 lines 15-20 of ‘718 patent points to a reference manual for isolating nucleic acid from bacteria. Additionally, lines 10-15 indicate that the nucleic acid can be introduced in mammalian cells. As such ‘718 patent discloses trans-kingdom transfer of nucleic acid, thus anticipating this claim.
Claim Objections
Claim 19 is objected to because of the following informalities: "trans-kingdom" is misspelled. Appropriate correction is required.
Conclusion
No claim is allowed or free of art.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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633