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 1-8, 10-14, 16-18, 20-21 and new claim 35 in the reply filed on 10/2/25 is acknowledged.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 18, 10-14, 16-18, 20 & 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0320137 (Fate) and US 2014/0255359 (Stowers).
Fate discloses a method for generating hematopoietic stem cells (HSCs) and progenitor cells from human pluripotent stem cells (nhPSCs) [0008]; iPSC derived hematopoietic lineage cells include, but not limited to, definitive hemogenic endothelium, hematopoietic multipotent progenitor cells, [0011]; one specific feeder
cell type may be a human feeder, [0155]) comprising the step of: a, preparing human pluripotent stem cells (nPSCs) (suitable for differentiating pluripotent stem cell-derived definitive hemogenic endothelium to pre-HSCs; and these culture media are provided
for generating pluripotent stem cell-derived hematopoiesis multipotent progenitors, [0015]); b. preparing a culture medium comprising a vascular endothelial growth factor (VEGF) and a glycogen synthase kinase-3 (GSK3) inhibitor (a culture medium comprising a ...VEGF ...a culture medium comprising ...a GSK3 inhibitor, (0016]), wherein said GSK3 inhibitor is to activate the canonical Wnt signaling pathway of said hPSCs (a medium comprising a Wnt pathway agonist, [0058]; the Wnt pathway activator is a GSKS3 inhibitor, [0243]; Wnt pathway activator ...is responsible for the induction of the definitive hematopoietic program from hiPSCs, [0350}); c. culturing the hPSCs in said medium for a period of time (culturing metastable pluripotent cells in media comprising a GSK3 inhibitor, [0182]; generating pluripotent stem cell-derived definitive hematopoietic cells using a multi-staged culture platform, [0236]). Fate also teaches addition of a stem cell factor (SCF) in the culture medium of step d for an improved constancy of batch to batch operation (a medium comprising one or more growth factors and cytokines selected from the group consisting of SCF [0014]; [t]he clonal expansion as disclosed further provides extensive homogeneity and therefore ensures product consistency, quality control and quality assurance, [0362], the culture medium of step c is the same as step d). Fate Therapeutics teaches wherein said downregulating transforming growth factor beta (TGF-beta) signaling pathway is effected by a TGF-beta inhibitor SB431542 (TGF beta receptor (e.g., ALKS5) inhibitors can include ...SB431542, [0185]). The functional concentration of said SB431542 ranges from about 0.2 uM to about 20 MM (TGF beta receptor (e.g., ALK5S) inhibitors can include ...SB431542 [0185] [0219]; SB431542 (0.04-10 uM), [0219], Table 1).
Fate doesn’t explicitly disclose and d. then downregulating the activated canonical Wnt signaling pathway or transforming growth factor beta (TGF-beta) signaling pathway for a period of time to induce and generate said hematopoietic stem cells (HSCs) however at the time the invention was filed, Stowers teaches and d. then downregulating an activated canonical Wat signaling pathway for a period of time to induce and generate hematopoietic stem cells (HSCs) (expanding the number of hematopoietic stem cells (HSC) ...wherein the HSC expansion media comprises ...a modulator of the Wnt pathway [0019]; preferably, the modulator of the Wnt pathway down-regulates GSK-3 beta, [0141]). Stowers also teaches that canonical signals in the Wat pathway which are involved in stem cell proliferation [0017]. Stowers teaches a concentration of said heparin ranges from about 0.2 to 20 ug/mL (a suitable base culture medium for HSCs is StemSpan Media ...which is supplemented with 10 ug/ml Heparin, [0213]).
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/ Primary Examiner, Art Unit 1657