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 (claims 1-7) and species (a) after introduction of an inducible SOX-18-encoding expression construct (claims 1-4 and 7) in the reply filed on 12/12/2025 is acknowledged.
Claims 1-17 are currently pending.
Claims 8-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/12/2025.
Claims 5-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
Claims 1-4 and 7 have been examined on their merits.
Claim Objections
Claim 1 is objected to because of the following informalities: The acronym “NK” should be spelled out at its first appearance in the claims as “natural killer cells (NK cells)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, the claim is dependent upon claim 1 and the phrase “the cells” in line 2 of the claim renders the claim indefinite because it is unclear which cells are being referred to in claim 1 as there are several different cell types recited in claim 1.
For examination purposes claim 7 will be interpreted as referring to the stem cells being differentiated.
Appropriate correction is required.
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) 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serrano et al (Blood 2010-from IDS filed 05/07/2024).
Regarding claims 1-4 and 7, Serrano disclose a method for increasing hematopoietic precursor cells, comprising enforcing expression of SOX18 in stem cells (Pg. 3895, Abstract). Sox18-enforced expression led to the enhanced proliferation of early hematopoietic precursors while blocking their maturation (Pg. 3895, right-hand column, last paragraph-Pg. 3896, left-hand column, first paragraph). Embryonic stem cell clones carrying Sox18-2AGFP construct {iSox18) using a doxycycline inducible system were established and compared to those without doxycycline. The iSox18 cells from day 5 EBs formed primitive and definitive hematopoietic colonies, whereas with doxycycline few primitive or definitive colonies were detected (page 3896 Figure 1A). On Sox18-enforced expression, a large number of colonies, blastic in appearance, developed...The iSox18+ blastic colonies were uniformly GFP+ (page 3896 Figure 1B) and besides Sox18, they expressed Gata1 and Sc1 indicative of hematopoietic specification (page 3896 Figure 1C)).
While Serrano does not specifically disclose the production of all the claimed cell types or wherein the enforcement of expression of SOX18 is in hemogenic endothelial cells during their transition from endothelium to hematopoietic progenitors, they do culture embryonic stem cells with expression of SOX18 enforced by doxycycline contact for at least 5 days (page 3896, Figure 1). This method provides the same conditions that Applicant has indicated are used to create the production of erythromyeloid progenitors, megakaryocytes and NK cells without differentiated T cells and increased NK production by about 5 fold compared with hemogenic epithelial cells wherein SOX18 is not enforced as evidenced by Applicant’s Specification (page 24 para 84, pages 25-27, para 86-89). Applicant’s disclosure indicates that treatment of ESC cultures with DOX enforced SOX18 from day 2 (D2) through day 8 (D8) resulted in the highest percentages of CD34+CD43+ HPs and CFCs and to a lesser degree in DOX4-6 cultures (page 26 para 87).
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.”
Therefore, since the steps recited in the claims require that stem cells are exposed to enforced expression of SOX18 and the Serrano method provides these steps, the results must inherently be the same unless they are due to conditions not recited in the claims.
Therefore, the teaching of Serrano anticipates Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kawaguchi et al., “Efficient production of platelets from mouse embryonic stem cells by enforced expression of Gata2 in late hemogenic endothelial cells”, Biochemical and Biophysical Research Communications, 2016, Vol. 474, pp. 462-468.
Randolph et al., “Direct induction of hemogenic endothelial progenitors from hPSCs by defined factors revealed by single-cell transcriptome analysis”, PNAS, March 20, 2021, pp. 1-25.
Yu et al., “Hematopoietic Precursor Cell Production by Programming”, WO 2012/109208.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631