DETAILED ACTION
Applicant’s amendment and Arguments/Remarks received on 02 February 2026 have been entered. Claims 1-2, 7, 10-11, 16, 19-22, 25, 28, 45, 47, 49-51, 53-54, and 59 were previously pending in the application. No claims have been cancelled, and no new claims have been added by Applicant. Claims 1-2, 7, 10-11, 16, 19-22, 25, 28, 45, 47, 49-51, 53-54, and 59 are currently pending in the application. Claims 1 and 53 are independent claims.
The election of Group I, drawn to a first nucleic acid, a baculovirus particle comprising the first nucleic acid, and a second nucleic acid, remains in effect in the instant application.
Claims 19-22, 25, 28, 45, 47, and 49-51 remain withdrawn from consideration as being directed to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-2, 7, 10-11, 16, 53-54, and 59 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2021/029749, filed 28 April 2021, which claims priority to U.S. Provisional Application No. 63/016,829, filed 28 April 2020.
Thus, the earliest possible priority for the instant application is 28 April 2020.
Specification
The objection to the specification of the disclosure for the Brief Description of the Drawings not including a description of each panel is withdrawn.
Claim Rejections - 35 USC § 112(b)
The rejection of amended and previously presented claims 1-2, 7, 10-11, 16, 53-54, and 59 under 35 U.S.C. 112(b) as failing to particularly point out and distinctly claim the subject matter which the inventor(s) regards as the invention for claim 1 reciting, ‘’wherein the modified Kozak sequence is selected from any one of SEQ ID NOs: 1-32, 51-52, 54, and 56-129”, claim 53 reciting, “a nucleotide sequence selected from any one of SEQ ID NOs: 1-32, 51-52, 54, and 56-129”, and claim 54 recites “a nucleotide sequence selected from any one of SEQ ID NOs: 13-14, 16-17, 22, 51-52, 54, and 56-129” and “a nucleotide sequence selected from any one of SEQ ID NOs: 52, 72-77, 78-83, 84-97, 115-117, and 119-122”, is withdrawn.
**The following new rejection is necessitated by amendments to the claims.
Amended claim 54 is newly rejected 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.
Independent claim 53 recites, “wherein the modified Kozak sequence is a nucleotide sequence comprising no more than 1, 2, or 3 nucleic acid variations relative to any one of the nucleotide sequences set forth in SEQ ID NOs: 1-32, 51-52, 54, and 56-129” in lines 3-6. Amended claim 54 is dependent on independent claim 53 and newly recites, “wherein the modified Kozak sequence comprises any one of the nucleotide sequences set forth in SEQ ID NOs: 13-14, 16-17, 22, 51-52, 54, and 56-129” in lines 1-3 and “wherein the modified Kozak sequence comprises any one of the nucleotide sequences set forth in SEQ ID NOs: 52, 72-77, 78-83, 84-97, 115-117, and 118-122” in lines 4-6, which are indefinite because the use of the verb “comprises” in claim 54 (“wherein the modified Kozak sequence comprises any one of the nucleotide sequences”, emphasis added) conflicts with the limitation in claim 53 using the verb “is” for the modified Kozak sequence (“wherein the modified Kozak sequence is a nucleotide sequence”, emphasis added). As such, the metes and bounds of the claim cannot be determined.
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.
**The following new rejection under 35 U.S.C. 102(a)(1) is necessitated by amendments to the claims.
Amended and previously presented claims 53 and 59 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kondratov et al. [2017, Molecular Therapy, 25(12), 2661-2675, IDS, cited in a prior action].
Regarding amended independent claim 53, note that claim 53 as amended does not require that the modified Kozak sequence have an upstream out of frame start codon nor that the modified Kozak sequence comprise a canonical ATG/AUG start codon.
Kondratov teaches a modified Kozak sequence UAGUGUAUGGC (“Kozak 4”), which is two nucleotides shorter than the sequence of instant SEQ ID NOs: 64 (CATAATGTATGGC) and 128 (GATAATGTATGGC) and further comprises one mismatched nucleotide with respect to each of SEQ ID NOs: 64 and 128 (i.e., the G at position 3 of the Kondratov sequence is mismatched to the A at position 5 of instant SEQ ID NOs: 64 and 128), wherein the modified Kozak sequence UAGUGUAUGGC is the optimal sequence among those tested for balancing the VP1/VP2/VP3 ratios for rAAV9 capsid production in Sf9 cells and for producing the highest infectivity in vitro [column 3 ¶ 1, column 4 ¶ 2, Table S1, Figure 1D, S2B]. Kondratov also teaches that the modified Kozak sequence is comprised in a plasmid construct and used for the expression of AAV9 capsid proteins VP1, VP2, and VP3 [column 4 ¶ 2].
Therefore, Kondratov teaches a nucleic acid comprising a nucleotide sequence encoding a modified Kozak sequence (UAGUGUAUGGC) and adeno-associated (AAV) VP1, VP2, and VP3 capsid proteins, wherein the modified Kozak sequence is a nucleotide sequence comprising no more than 3 nucleic acid variations relative to instant SEQ ID NOs: 64 and 128.
Regarding claim 59, Kondratov teaches wherein the Kozak sequence UAGUGUAUGGC is used to express rAAV VP1, VP2, and VP3 capsid protein from an AAV9 serotype [column 4 ¶ 2, Table S1].
Accordingly, by teaching all of the limitations of amended and previously presented claims 53 and 59, Kondratov anticipates the instant invention as claimed.
Insofar as Applicant’s arguments apply to this new grounds of rejection, Applicant argues that Kondratov does not disclose or suggest the claimed nucleic acids.
However, this not agreed.
As discussed above, Kondratov discloses the modified Kozak sequence of UAGUGUAUGGC, which comprises 3 variant nucleotides compared to the sequences of instant SEQ ID NOs: 64 and 128. Therefore, Applicant’s arguments do not overcome the finding of anticipation under 35 U.S.C. 102(a)(1) over Kondratov.
Claim Rejections - 35 USC § 103
The rejection of amended and previously presented claims 1, 7, 10-11, 16, 53, and 59 under 35 U.S.C. 103 as being unpatentable over Kondratov et al. [2017, Molecular Therapy, 25(12), 2661-2675, IDS]; in view of Kozak [1995, Proceedings of the National Academy of Science, 92, 2662-2666]; is withdrawn in view of Applicant’s claims which now recite “wherein the modified Kozak sequence comprises any one of the nucleotide sequences set forth in SEQ ID NOs: 1-32, 51-52, 54, and 56-129 (amended independent claim 1) such that that alternative limitation for “wherein the modified Kozak sequence comprises an out of frame upstream initiation codon” has been removed from each independent claim.
Allowed Subject Matter
Claims 1-2, 7, 10-11, and 16 are considered free of the prior art of record and are allowed at this time.
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 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 Dr. KATIE L PENNINGTON whose telephone number is (703)756-4622. The examiner can normally be reached M-Th 8:30 am - 5:30 pm, Friday 8:30 am - 12:30 pm CT.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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