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 III, claim 12 in the reply filed on 08/13/2026 is acknowledged.
Claims 1-11 and 13-16 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/13/2026.
Claim Objections
Claim 12 objected to because of the following informalities: the first letter of each step should not be capitalized as claims are to be only a single sentence. Thus, capitalization at the beginning of each step is not necessary. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12 is/are rejected under 35 U.S.C. 102a1 and 102a2 as anticipated by US2015015950 (Lim, IDS).
Claim 12 is drawn to a method of extracellular vesicle (EV) preparation comprising (i) providing an immortalized target cell, (ii) culturing the cell in a medium to produce an EV enriched medium, (iii) harvesting the EVs from the medium and (iv) optionally testing the EVs for therapeutic activity.
Lim teaches transforming (immortalizing) umbilical mesenchymal stem cells (target cell with a finite lifespan) for the production of secreted exosomes (extracellular vesicles). Lim teaches a variety of ways to immortalize cells including use of transgenes encoding mutant p53 and hTert (see paragraphs 219-222).
Claim 12 recites that the cells are immortalized according to the method of claim 1. Claim 1 need only be considered to the extent that it influences the structure of the immortalized cell. Claim 1 requires contacting the target cell (umbilical cord MSC of Lim) with a genetic expression construct encoding hTERT protein and an inhibitor of the expression of p21, p15 or p53. Lim teaches hTert as a transforming gene at paragraph 221. With regard to an inhibitor of p53, Lim refers to Weinberg (1991, Science, 254:1153-1161) who teaches that mutant p53 binds to wild-type monomers and “poisons” the complex as a whole. Thus, Lim teaches immortalization of MSCs by expression of Tert and inhibiting function of p53.
At para 231-245, Lim teaches culture of the MSCs in medium to make MSC-conditioned (enriched) medium comprising secreted molecules and particles including vesicles or exosomes. Lim teaches isolation (harvesting) of the particles beginning at para 255. Lim teaches testing the therapeutic activity (e.g. cardioprotective activity) at para 260.
Thus, Lim anticipates all of the limitations of claim 12.
Conclusion
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/ Primary Examiner, Art Unit 1632
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