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 .
Receipt and entry of the response dated 12/17/2025 is acknowledged.
Claim Rejections - 35 USC § 112
The rejection of claim 12 as improperly dependent is withdrawn in light of amendment of the claim and applicant’s remarks.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 9, 16, 17, 24, 26, 27, 29-31, 33, 35, 38, 40 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zhang et al (PLoS ONE, 2013, of record) as evidenced by Palmer et al (Mol. Ther., 2013). This rejection is maintained for reasons made of record in the Office Action dated 6/18/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive. Applicant’s essentially assert that Zhang et al do not teach or suggest that the transposon payload can be up to 15 or 36 kb.
Such is false for reasons of record. The plain meaning of Zhang et al is that the adenoviral vectors can incorporate and deliver a transgene payload of up to 36 kb, said transgene may be a transposon-based transgene as exemplified by Zhang et al. Zhang et al (nor the remainder of the relevant art) do not teach that such a transgene payload is limited to specific types of transgenes, such as a transposon. That Zhang et al specifically exemplified a transposon payload of from 4-5 kb does not diminish the other teachings of Zhang et al regarding potential payload size of up to 36 kb. Further, prior art is presumed to be enabling, absent evidence to the contrary. No such evidence has been provided. Rather, large transgene payloads are delivered by such adenoviral vectors routinely (e.g. 23-kb LCR of Lieber et al, below, and Palmer et al teaches up to 37 kb in the first ¶). Applicants present no evidence of surprising results upon delivery of transposon payload larger than that of Zhang et al, and do not detail any specific art-recognized problem, vector component or method step that might provide unpredictability. Finally, it is noted that the vectors and methods of the instant claims use the same components established in the prior art to provide delivery of large (~30 kb) transgene payloads, thus, the ability to so deliver such transgene payloads is an inherent feature of the vectors.
Claim(s) 1-6, 9, 12, 16, 17, 21, 24, 26, 27, 29-31, 33, 35, 38, 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (PLoS ONE, 2013, of record) as applied to claims 1-5, 9, 16, 17, 24, 26, 27, 29-31, 33, 35, 38, 40 above, and further in view of Lieber et al (US 20170037431 A1, of record). This rejection is maintained for reasons made of record in the Office Action dated 6/18/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive. Applicant’s essentially assert that Lieber et al does not remedy the deficiencies of Zhang et al.
Such is not convincing for reasons set forth above. Further, it is noted the beta-globin “long” LCR sequences of Lieber et al are 23 kb (¶ [0151]) and correspond to specifically claimed transposon payloads, and the delivery of payloads greater than 15 kb is taught throughout (¶’s [0014], [0043], [0073], [0160], [0168]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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