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 .
Status of the Claims
Claims 1-10, 12-13, 17-18, 22-28, 32-35, 37, 41, and 48 are pending.
Applicant’s election without traverse of group I claims 1-10 in the reply filed on 5/11/2026 is acknowledged. Claims 12-13, 17-18, 22-28, 32-35, 37, 41, and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
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.
Fitcher
Claims 1-2, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Fichter, Christina et al. “Modular Lentiviral Vectors for Highly Efficient Transgene Expression in Resting Immune Cells.” Viruses vol. 13,6 1170. 18 Jun. 2021
Regarding claim 1, 2, and 10 Ficther teaches an MS2 lentivirus-like particle (LVLP)-based RNA delivery platform to deliver a transgene of interest to resting CD4+ T cells. (Fitcher, Abstract, Conclusions). Fichter teaches that their LVLP comprises a protein shell (MS2) that may comprise Vpx protein as a protein of interest, which is released into the cytoplasm of target cells following vector entry. (Ficther, pg 7, second paragraph).
Allowable Subject Matter
Claims 3-9 are objected to as being dependent upon a rejected base claim, but would be free from the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Appropriate correction is required.
Claims 3-9 are free of the art. There does not appear to be a teaching or suggestion in the prior art to modify a VLP with a homing molecule that is specifically a CXCR4 polypeptide fused to a viral protein R (VPr) fragment.
Frank is a review article that discusses surface-engineered lentiviral vectors for selective gene transfer into subtypes of lymphocytes (i.e., homing molecules). (Frank, Abstract). Frank fails to teach or suggest a fusion of CXCR4 and Vpr fragment.
There is no teaching or suggestion in the prior art for this fusion fragment as a homing molecule until the concept appears in Felker. Felker however is not only derived from the inventors of the present application, but also does not qualify as prior art as it was published after the priority date of this application.
Frank, Annika M, and Christian J Buchholz. “Surface-Engineered Lentiviral Vectors for Selective Gene Transfer into Subtypes of Lymphocytes.” Molecular therapy. Methods & clinical development vol. 12 19-31. 17 Oct. 2018
Felker, Sydney et al. “Differential CXCR4 expression on hematopoietic progenitor cells versus stem cells directs homing and engraftment.” JCI insight vol. 7,9 e151847. 9 May. 2022 (Provided in IDS of 1/11/2024)
Conclusion
Claims 1-2 and 10 are rejected.
Claims 3-9 are objected to.
Claims 12-13, 17-18, 22-28, 32-35, 37, 41, and 48 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS R. AMICK/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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