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 .
Applicant’s election without traverse of Group I claims 55-69 in the reply filed on 12/09/2025 is acknowledged.
Claims 70-86 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/09/2025.
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 applications GB2001996.4 and GB2017820.8 filed 02/13/2020 and 11/11/2020 respectively.
This application claims the benefit of priority to Patent Application PCT/GB2021/050247. Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/GB2021/050247, filed on 02/04/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 08/14/2022, 04/09/2023, 04/25/2023, 02/16/2024, 07/13/2024, 12/10/2024, 03/31/2025, and 12/09/2025 have been considered by the Examiner.
Status of Claims
Claims 55-69 are under examination.
Claims 70-86 are withdrawn.
Claim 1-54 are cancelled.
Claim Objections
Claims 56, 60-62, and 65 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
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 57 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. The phrase “a nucleic acid of interest” does not define the metes and bounds of the invention in the claim and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The indefinite phrasing does not clearly define what the gene could be.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 55, and 57-59, 63-64, 66, and 67-69 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (WO-00-00600) in view of Ozsolak et al. (US 2018/0311176 Al).
Regarding claim 55, Chang et al. teach a packaging vector comprising a nucleotide sequence encoding Gag and Pol proteins of a reference lentivirus. Chang et al. teach the packaging vector’s major splice donor site is either deleted, or if provided, while functional, differs in sequence from that of said reference lentivirus sufficiently so that said major splice donor site is not a potential site for homologous recombination between the packaging vector and the reference lentivirus, and it lacks a functional major packaging signal (cover page, abstract). Chang et al. further teach deletion of the cryptic splice site in SL2 (page 228, lines 26-30).
Ozsolak et al. teach particle formulations and methods for delivery of oligonucleotides. Ozsolak et al. teach compositions and methods that are useful for protecting RNAs from degradation. Ozsolak et al. teach a nucleic acid comprises SEQ ID NO: 868 which is the same as SEQ ID NO: 7 of the present application.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Chang et al. for a lentiviral packing vector with the teachings of Ozsolak et al. for the nucleic acid SEQ ID NO:868. Ozsolak et al. provide motivation by teaching that the oligonucleotides are useful for stabilizing RNAs by preventing or inhibiting degradation. One of skill in the art would have had a reasonable expectation of success at combining Chang et al. and Ozsolak et al. because both teach methods for nucleic acid delivery.
Regarding claim 57, Chang et al. teach transducing vector is an expression vector which bears an expressible nonlentiviral gene of interest (page 51, lines 1-6).
Regarding claim 58, Chang et al. teach the construct contains a chimeric CMV-TAR promoter. Chang et al. further teach the elimination of U3 sequence from the vector system greatly improved the safety (page 198, lines 1-5).
Regarding claim 59, Chang et al. teach the substitution of 3' U5 with bGHpA exhibited self-inactivating (SIN) phenotype after transduction, transduced both dividing and non-dividing cells at similar efficiencies, and produced vector titers twice as high as that of the wild type construct. Chang et al. teach both safety and efficacy of the HP/TV vector have been improved by LTR modifications (page 210, 20-29).
Regarding claim 63, Chang et al. teach a gene expression cassette (page 241, lines 21-24).
Regarding claim 64, Chang et al. teach a packaging cell which comprises the packaging vector and is suitable for production of lentivirus-like particles (page 248, claim 21). (i) Chang et al. teach the substitution of 3' U5 with bGHpA exhibited self-inactivating (SIN) phenotype after transduction, transduced both dividing and non-dividing cells at similar efficiencies, and produced vector titers twice as high as that of the wild type construct. Chang et al. teach both safety and efficacy of the HP/TV vector have been improved by LTR modifications (page 210, 20-29). Chang et al. further teach the elimination of U3 sequence from the vector system greatly improved the safety (page 198, lines 1-5). (ii) Chang et al. teach the nucleotide sequences encoding gag, pol, env (page 5, lines 20-21), and rev (page 10, lines 1-2). wherein the lentiviral vector production system allows for the inactivated or deleted tat (page 40, table).
Regarding claim 66, Chang et al. a packaging cell which comprises the packaging vector and is suitable for production of lentivirus-like particles (page 248, claim 21).
Regarding claim 67, Chang et al. teach transducing vector is an expression vector which bears an expressible nonlentiviral gene of interest (page 51, lines 1-6).
Regarding claim 68, Chang et al. a packaging cell which comprises the packaging vector and is suitable for production of lentivirus-like particles (page 248, claim 21).
Regarding claim 69, Chang et al. teach a method for producing a lentiviral vector, where the method comprising introducing the viral vector production system into a cell (page 6, lines 15-17).
Conclusion
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights