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 .
Applicants’ response filed on 02/03/2026 is acknowledged and has been entered into the application file.
Election/Restrictions
Applicants has previously elected without traverse Group II, drawn to a method for direct conversion of a somatic cell into a myeloid cell in vitro, the method comprising bringing or inserting, into contact with or into a somatic cell, a composition comprising at least one selected from the group consisting of:(1) a friend leukemia virus integration 1 (FLIl) protein; (2) a nucleic acid molecule encoding the protein; and (3) a vector into which the nucleic acid molecule is introduced, in the reply filed on 09/09/2025.
Claims 1-15 were pending in the instant application. Claim 14 is cancelled. Claims 1-4, 6-12 are still withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 09/09/2025. Claims 5, 13, and 15 are therefore under examination in the instant application.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claim(s) 5, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wenge et al.:
Applicants have traversed the rejection asserting that the presently claimed invention relates to a method for direct conversion of a somatic cell into a myeloid cell having normal physiological functions that is applicable for therapeutic purposes while Wenge et al. discloses that introduction of an MN1-FLIT gene fusion (oncofusion) protein identified in pediatric acute megakaryoblastic leukemia (AMKL) into mouse-derived hematopoietic progenitor cells (HPCs) is sufficient to induce conversion into acute megakaryoblastic leukemia (AMKL) cells. Applicants further argue that the present invention as claimed in claim 5 relates to a method of direct transdifferentiation that utilizes the intrinsic transcriptional regulatory function of FLIT alone to convert the fate of a somatic cell into a normal myeloid cell.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “myeloid cell having normal physiological functions” and “normal myeloid cell” ) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument of utilizing the intrinsic transcriptional regulatory function of FLIT alone to convert the fate of a somatic cell into a normal myeloid cell, although Wenge et al. discloses MN1–FLI1-
mediated leukemic transformation generates an AMKL phenotype via abnormal transcriptional activation of FLI1, the MN1–Fli1 retains the essential DNA-binding and transactivating functions of wild-type Fli1.
Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive. The rejection is therefore maintained.
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.
(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) 5, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wenge et al. (Wenge
et al., “MN1–Fli1 oncofusion transforms murine hematopoietic progenitor cells into acute megakaryoblastic
leukemia cells”. Oncogenesis 4, e179 (2015)).
Regarding claim 5, Wenge et al. teaches retrovirally expressing MN1–FLI1 or an empty vector control in
primary murine c-kit+ hematopoietic progenitor cells (HPCs) derived from the bone marrow of C57Bl/6 mice and
assessed their effect on in vitro colony replating capacity as a surrogate measure of self-renewal (page 1, column 1,
paragraph 2, lines 1-6). Wenge et al. also teaches that expression of MN1–FLI1 in murine hematopoietic progenitor
cells was sufficient to induce leukemic transformation generating immature myeloid cells with cytomorphology and
expression of surface markers typical for acute megakaryoblastic leukemia (AMKL) (Abstract). This reads on a
method for direct conversion of a somatic cell (hematopoietic progenitor cell) into a myeloid cell, comprising bringing into contact with a somatic cell a composition comprising a vector expressing a friend leukemia
virus integration 1 (FLI1) protein.
Regarding claim 13, Wenge et al. teaches that the FLI1-transformed cells showed the phenotype
of immature megakarypoietic cells, and mostly megakaryoblasts (page 1, column 2, paragraph 1, lines 10-
12).
Regarding claim 15, Wenge et al. teaches retrovirally expressing MN1–FLI1 in primary murine
c-kit+ hematopoietic progenitor cells in vitro (page 1, column 1, paragraph 2, lines 1-6). This reads on that
the vector is a retrovirus vector.
Conclusion
THIS ACTION IS MADE FINAL. 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 HANAN ISAM ABUZEINEH whose telephone number is (571)272-9596. The examiner can normally be reached Mon- Fri 8:30-5:00.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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