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 .
Election/Restrictions
Applicant’s election without traverse of Group I and species of an antibody in the reply filed on 8/11/2026 is acknowledged.
Applicant further elected, without traverse, the antibody species of claim 14 in a telephone call on 9/17/2026.
Status of the Claims
Claims 22, 25-26, 51, 55, 59 and 61-63 have been withdrawn as being directed to a non-elected invention. Claims 11, 13 and 18 have been withdrawn as being directed to a non-elected species. Claims 1-2, 8, 10, 14-15, 19 and 46 are under examination at this time.
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.
Claim(s) 1, 2, 8 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (International Journal of Nanomedicine, 2018,13:5347–5359; cited by applicant).
The instant claims are directed to a functionalized biological membrane comprising (a) an endogenous bilayer, (b) a modifying protein molecule, and (c) a releasable cargo.
Chen et al. teaches a nanosystem which uses RBCm-derived microvesicles as carriers for paclitaxel (PTX) with anti-EGFR-iRGD as a tumor-targeting molecule inserted in the microvesicle.
The recombinant protein anti-EGFR-iRGD was used to prepare DSPE-PEG-anti-EGFR-iRGD, which was then inserted in RBC membranes (RBCm). A mixture of anti-EGFR-iRGD decorated RBCm and PTX was then extruded through 200 nm pores for at least 13 times, so that the mechanical force of the extruding process facilitated the encapsulation of PTX into the RBCm vesicles (RBCm-PTX) [claim 1, parts (a), (b) and (c)] (see Figure 1 below). The PTX is a releasable cargo.
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For claims 2 and 8, the modifying protein (anti-EGFR-iRGD) is inserted into the RBC membrane via DSPE, a modifying lipid molecule, and the endogenous bilayer comprises an erythrocyte bilayer.
Thus, Chen et al. anticipates the claimed invention.
Claim(s) 1, 2, 8, 10, 14-15, 19 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xia et al. (J Gene Med, 2008, 10:306–315; cited by applicant).
The instant claims are directed to a functionalized biological membrane comprising (a) an endogenous bilayer, (b) a modifying protein molecule, and (c) a releasable cargo.
Xia et al. teaches the use of Trojan horse liposomes (THLs) [claim 1, part (a)] targeted with a monoclonal antibody (MAb) to the rat transferrin receptor (TfR) [claim 1, part (b) and claims 2, 10, 14-15 and 19], where the THLs are loaded with glial-derived neurotrophic factor (GDNF) plasmid DNA [claim 1, part (c)] (see the abstract).
Specifically, Xia et al. teaches that the GDNF plasmid DNA [claim 19] is encapsulated in the interior of 100 nm liposomes, and the surface of the liposome is conjugated with several thousand strands of polyethyleneglycol (PEG) [claim 8]. The tips of 1–2% of the PEG strands are conjugated with a receptor-specific monoclonal antibody (MAb), such as an MAb to the transferrin receptor (TfR) [claim 2, part (a) and claims 10, 14 and 15]. The TfR is expressed on both the BBB and on the neural cell membrane. The MAb portion of the THL binds the TfR, and this triggers receptor-mediated transport across the BBB, followed by receptor-mediated endocytosis into neurons behind the BBB. Exogenous plasmid DNA is widely expressed in brain following intravenous injection of THLs [claim 46] in rats, mice and Rhesus monkeys (see page 307, left column).
Thus, Xia et al. anticipates the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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