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 arguments filed on 1/16/2026 have been entered.
Claims 1, 11, 20 and 25 have been amended.
Claim 10 has been cancelled.
The objection and rejection to claim 20 are withdrawn in view of Applicant’s amendment.
The 102 rejection of record was amended to correct a typographical error. Vodyank does not produce CD35+ cells, but rather CD34+.
Claims 1, 5-7, 11-18, 20, 21, 25, 28 and 30-32 are examined in the instant application.
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, 5-7, 11-18, 20, 21, 25, 28 and 30-32 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vodyank et al. (WO 2018/195175 A1, cited on IDS filed on 7/21/2023) for reasons of record in the Non-Final Office Action mailed on 10/21/2025 (and repeated as amended below).
Claim Interpretation: while Vodyank et al. do not explicitly recite the term “early mesoderm”, but rather mesoderm differentiated from pluripotent stem cells (PSC), it is interpreted that the mesoderm cells of Vodyank are early mesoderm cells as instantly claimed. The specification defines “early mesoderm” at parag. 51 on pg. 7 as “Where used herein, the term “early mesoderm cells” or “mesoderm precursor cells” are precursors of hematopoietic stem and progenitor cells. They may be isolated from an appropriate tissue, such as embryos (e.g. aorta-gonad-mesonephros) or are differentiated from PSC.” Accordingly, it is interpreted that the mesoderm cells taught by Vodyank early mesoderm cells since they are differentiated from PSCs and can be differentiated into CD34+ hematopoietic progenitor cells as instantly claimed.
Regarding claims 1 and 25, Vodyank et al. a method of differentiating PSCs into CD34+ hematooietic progenitor cells using a culture medium supplemented with TPO, SCF and FLT3L (parag. 244 and Fig. 1B). It should be noted that VEGF is an optional supplement for their medium and thus can be excluded.
Regarding claims 5, 15 and 28, Vodyank teaches that their medium is serum-free (parag. 243).
Regarding claims 6 and 16, Vodyank teaches that their method was free of feeder-cells (parag 9).
Regarding claim 7, Vodyank teaches that culturing was between 3 and 15 days (Fig. 1B).
Regarding claim 10, Vodyank teaches deriving a population of early mesoderm cells from PSCs (Fig. 1B).
Regarding claims 11-14 and 30-32, Vodyank teaches using BMP4, FGF2 and VEGF to derive early mesoderm from PSC (Fig. 1B).
Regarding claim 17, Vodyank teaches that the derivation of early mesoderm is between 1 and 7 days (Fig. 1B).
Regarding claim 18, Vodyank teaches forming the PSC into aggregates (parag. 242).
Regarding claim 20, Vodyank teaches using a Vibronectin-coated 6-well plate to form aggregates (parag. 242). It is interpreted that the Vibronectin-coated plate is a microwell device.
Regarding claim 21, Vodyank teaches differentiating CD34+ progenitors into lymphoid progenitors under serum-free conditions (Fig. 1A and parags. 197 and 202).
Thus Vodyank clearly anticipated the invention of claims 1, 5-7, 10-18, 20, 21, 25, 28 and 30-32.
Response to Arguments
Applicant’s Arguments
Applicants argue in amendment that Vodyank discloses that PSC to mesoderm induction involves two stages, and two different media. First, PSCs are exposed to a WNT-induced priming step in E8 medium for 2 days, and next mesoderm is induced in a differentiation medium after 3 days in culture (see paragraphs [0178] and Example 2).
Therefore, claim 1 is distinguishable from D1 by requiring that early mesoderm cells arise in a single derivation medium rather than in two different media formulations. Such a differentiation workflow with a reduced number of media formulations could greatly reduce reagent expenses and workflow complexity and bring down the overall costs for producing large-scale HSPCs required for clinical applications.
Applicants continue that claim 25 has been amended to specify that the medium is supplemented with one or both of an exogenously added agonist of BMP signaling and an exogenously added agonist of fibroblast growth factor (FGF) signaling and that the medium excludes an exogenously added agonist of vascular endothelial growth factor (VEGF) signaling and IL-3.
With regard to claim 25, Vodyank discloses differentiating hematopoietic CD34+ progenitors in a medium supplemented with SCF, TPO, FLT3L and IL-3 (see para [0244] & Fig. 1B). Vodyank does not teach or suggest a medium comprising one or both of an exogenously added agonist of BMP signaling and an exogenously added agonist of FGF signaling, while excluding an exogenously added agonist of VEGF signaling and IL-3, as claimed. In fact, Vodyank teaches IL-3 as a component of the differentiation medium used for the differentiation of hematopoietic progenitors (see at least para [0193] and fig. 1B).
Therefore, claim 25 is distinguishable from D1 by requiring that the medium comprises one or both of an exogenously added agonist of BMP signaling and an exogenously added agonist of fibroblast growth factor (FGF) signaling and excludes an exogenously added agonist of vascular endothelial growth factor (VEGF) signaling and IL-3.
Examiner’s Response
While Applicant’s arguments have been fully considered they are not found persuasive. Claim 1 only requires one operable step, culturing a population of early mesoderm cells in a first medium. While the preamble is drawn to differentiating CD34+ hematopoietic progenitor cells, there are no CD34+ cells used/produced in the method of claim 1 or the dependent claims. Only early mesoderm cells are provided in the claims and what the early mesoderm cells are differentiated into is not claimed. Further, in view of the new amendment to the claims, these are also not persuasive. While the early mesoderm cells may be derived from PSCs in a derivation medium comprising a second basal medium, this does not change the early mesoderm cells of the claims in a structural or functional way that would distinguish them from the early mesoderm cells taught by Vodyank. It is maintained that Vodyank teaches culturing early mesoderm cells as instantly claimed. Thus for the reasons above and of record the rejection is maintained.
Conclusion
No claims are allowed.
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 DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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DAVID A. MONTANARI
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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