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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/7/2026 has been entered.
Withdrawn Rejection
The rejection of claim(s) 1-10 and 18-21, under 35 U.S.C. 103 as being unpatentable Kaji (WO 2021/041858 A1 pub date:3/4/2021 effectively filed: 8/29/2019) in further view of Sturgeon (Sturgeon et al. Nature Biotech 32(6):554-562), is withdrawn.
The rejection of claim(s) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable Kaji (WO 2021/041858 A1 pub date:3/4/2021 effectively filed: 8/29/2019) and Sturgeon (Sturgeon et al. Nature Biotech 32(6):554-562), as applied to claims 1-10 and 18-21, in view few of Translation (English translation for C111235105B published 8/10/2021, pages 1-20), is withdrawn.
These rejections are being withdrawn because while a closer review of Sturgeon elucidates that the Wnt inhibitor is being used in the process of arriving at mesoderm cells. There is clear indication of producing mesoderm cells from embryoid culture with wnt activator to produce mesoderm cells and then culturing the mesoderm cells with a Wnt inhibitor to produce hemogenic endothelial cells. A review of the further suggests that mesoderm cell culture with a Wnt inhibitor leads to cardiac cell formation not hemogenic endothelial cells. (see Willems et al. Circulation research 109(4):360-361, 2011). As such, the rejections are withdrawn and application arguments are persuasive in overcoming the 103 rejections.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-15 and 18-22, as amended, previously presented or originally presented, remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 49-52 of copending Application No. 18/025,590 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims have overlapping, non-mutually exclusive subject matter.
Regarding claim 1, copending claim 49 discloses method for promoting the directed differentiation of pluripotent stem cells (PSCs), comprising the steps of: contacting the PSCs with a maintenance culture medium to form embryoid bodies (EBs); contacting the EBs with a first differentiation culture medium supplemented with a Wnt signaling activator, or with the first differentiation culture medium supplemented with a Wnt signaling activator and a second differentiation culture medium supplemented with a Wnt signaling activator sequentially, to form mesodermal cells; contacting the mesodermal cells with a third differentiation culture medium supplemented with a Wnt signaling inhibitor to form hemogenic endothelial (HE) cells. Claim 49 further more narrowly specifies the Wnt signaling pathway activation in the second differentiation culture medium is same or different and has an equal or lower concentration as compared to the Wnt signaling pathway activator in the first differentiation culture medium. As such, copending claim 49 discloses an anticipatory species of instant claim 1, rendering claim 1 obvious.
Regarding claim 2, copending claim 49 further recites contacting the HE cells with a fourth differentiation culture medium to form hematopoietic progenitor (HP)cells. As such, copending claim 49 discloses an anticipatory species of instant claim 2, rendering instant claim 2 obvious.
Regarding claim 3, copending claim 49 further recites contacting the HP cells with a fifth differentiation medium to obtain immature iNK cells. As such copending claim 49 discloses an anticipatory species of instant claim 3, rendering it obvious.
Regarding claim 4, copending claim 49 specifies the Wnt signaling pathway activation in the second differentiation culture medium is same or different and has an equal or lower concentration as compared to the Wnt signaling pathway activator in the first differentiation culture medium as claimed in claim 4. Copending claim 49 also additionally contacts the result HE cell with a medium to form HP cells and then contacting the HP cells with another medium to obtain immature iNK cells. As such, claim 49 has a narrower scope than claim 4. Thus, claim 49 is an anticipatory species of instant claim 4.
Regarding claim 5, copending claim 49 specifies the Wnt signaling pathway activation in the second differentiation culture medium is same and has a lower concentration as compared to the Wnt signaling pathway activator in the first differentiation culture medium as claimed in claim 5. Copending claim 49 also additionally contacts the result HE cell with a medium to form HP cells and then contacting the HP cells with another medium to obtain immature iNK cells. As such, claim 49 has a narrower scope than claim 5. Thus, claim 49 is an anticipatory species of instant claim 5.
Regarding claim 6, copending claim 49 teaches the limitation of the method of claim 6 as discussed above. Copending claim 49 does not species that the second medium has a Wnt activator concentration at a range of 0 to 4 µM and the first medium has a Wnt activator concentration at a range of 4 to 8 µM. However, at the time of the copending and instant claims determining optimal concentrations of Wnt activator in the two different differentiation mediums of copending claim 49 was routine optimization in the art. As such, it would have been obvious to choose from a finite number of possible concentration for the Wnt activator in the first and second medium to predictable arrive at the Wnt activation concentration claim through routine optimization using well established optimization protocol. As such, copending claim 49 is an obvious species of instant claim 6.
Regarding claim 7, copending claim 50 teaches the concentration of the third differentiation medium is from 1 to 30 µM. As such, claim 50 is an anticipatory species of claim 7 for reasons discussed above.
Regarding claim 8, copending claim 51 teaches the same list of Wnt activator species as instant claim 8. Thus claim 51 is an anticipatory species of instant claim 8 for reasons discussed above.
Regarding claim 9, copending claim 49 teaches the Wnt inhibitor as discussed above. Copending claim 49 does not teach the species listed in claim 9 for the Wnt inhibitor. However, many of the Wnt inhibitors (such as the IWPs and XAV0939) if not all were art established Wnt inhibitor available for use in the method of claim 49 As such, copending claim 49 is an obvious variant of instant claim 9.
Regarding claim 10, copending claim 52 recites that same limitations as instant claim 10. As such, copending claim 52 is an obvious variant of instant claim 10 for reasons discussed above.
Regarding claim 11, copending claim 49 specifies the basal medium is supplemented with a combination of (i) a nicotinamide-based compound; (ii) heparin-based compound; and/or (iii) a human platelet lysate in the fourth and fifth medium. As such, copending claim 49 is an obvious variant of instant claim 11.
Regarding claim 12-14, These claims specify the concentrations for the nicotinamide-based compound, the heparin-based compound, and the human platelet lysate, which copending claim 49 does not teach. However, optimizing concentrations is routine optimization. As such, copending claim 49 is an obvious variant for instant claims 12-14.
Regarding claim 15, copending claim 49 does not teach the species of nicotinamide and heparin sodium. However, nicotinamide is the most obvious species of a nicotinamide-based compound and heparin sodium is a commonly-used well established species of a heparin based compound. As such, it would have been obvious to used these common forms of nicotinamide and heparin as claimed in claim 15 in the method of copending claim 49.
Regarding claim 18, copending claim 49 does not teach that the base medium is the same. However, often the same base medium is used throughout a differentiation method and thus it would have been obvious to an artisan to use the same medium in copending claim 49 throughout. As such, copending claim 49 is an obvious variant of claim 18.
Regarding claim 20, copending claim 49 does not expressly teach the use of a serum free, xeno-free chemically defined medium. However, before filing, the advantages of using serum-free, xeno-free, chemically-defined medium were well established in the art for clinical application. As such, it would be obvious to use such medium as defined by claim 20 in the method of copending claim 49 with a reasonable expectation of success.
Regarding claim 21, copending claim 49 discloses the culture is of an EB which is a 3D culture condition. As such, copending claim 49 is an obvious variant of instant claim 21.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In the remarks, Applicant requests that the provisional double patenting rejection be held in abeyance until allowable subject matter is identified. In response, the rejection is maintained.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
Prosecution Insights