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 .
Claim Status
Applicant’s submission filed 09/05/2025 has been received and entered. Claims 9, 11 and 13 have been amended. Accordingly, claims 9-17 are pending and under current examination.
Status of Prior Rejection/Response to Arguments
The rejection of claims 9-17 under 35 USC §112(b) is withdrawn:
Applicant’s amendment to claim 9 deletes “high”, and the amendment to claims 11 and 13 delete the phrase “and the like” obviates the current objection on record. Therefore, the objection is withdrawn.
The rejection of clams 9-17 under 35 USC §102(a)(1)and (a)(2) over Tzu-bi Shih is withdrawn:
Applicant ‘s amendment to claim 9 recites the limitation that pluripotent stem cells that are “CD133-positive, SSEA-3 positive, and CD-34-negative”, since Tzu-bi Shih teaches that MCPCs expressing CD34- also has CD133- (see Table 3,parag 0081), the amendment is effective to obviate the prior basis of the rejection. The rejection is withdrawn.
The new ground of rejection is necessitated by Applicant’s amendment.
New Ground of claim Rejection
New Claim Rejections - 35 USC § 112-New matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection necessitated by Applicant’s amendment.
In the submission, Applicant’s amendment to the independent claim 9 limits the pluripotent stem cells are CD133- positive, SSEA-3 positive, and CD-34 negative. The Specification discloses the human amnion-derived SSEA-3-positive cells (cell population isolated from an extraembryonic tissue), the double positivity of SSEA-3 and CD133 was 71.5% (p39, L4-6). Besides, the specification teaches CD34 was not expressed in the human amnion-derived MSCs and human amnion-derived SSEA-3-positive cells, as in the bone marrow-derived MSCs and Muse cells (p39, L8-9). These teachings disclose a cell population (human amnion-derived SSEA-3-positive cells) comprising >50% (i.e., 71.5%) of the pluripotent stem cells are CD133- positive, SSEA-3 positive, and CD-34 negative. However, there is no support about a cell population isolated from embryonic tissue comprising 50% or more of the pluripotent stem cells having CD133- positive, SSEA-3 positive, and CD-34 negative. The specification teaches bone marrow-derived MSCs and Muse cells do not express CD34 (p39, L8-9), but only 2.0% of the SSEA-3-positive cells in the bone marrow-derived Muse cell was CD133-positive. The specification does not specifically teach the cell surface markers of other embryonic tissue such as peripheral blood, fat, and skin. Therefore instant disclosure does not have support for the cell population isolated from an embryonic tissue comprising 50% or more of the CD133- positive, SSEA-3 positive, and CD-34 negative pluripotent stem cells.
Related Prior arts
Instant claims are directed to a cell population comprising pluripotent stem cells that are CD133-positive, SSEA-3 positive, and CD-34-negative, wherein the cell population has been isolated from an extraembryonic tissue or embryonic tissue, and includes 50 % or more of the pluripotent stem cells. Ramuta et al. (Cell Transplant. 2018 Jan;27(1):77-92) and Pavon et al. (Oncotarget. 2016 Jun 28;7(26):40546-40557) are considered as two closet prior arts. Ramuta et al. teach human amniotic membrane (hAM) and amniotic membrane–derived cells (including human amniotic epithelial cells [hAECs] and human amniotic mesenchymal stromal cells [hAMSCs]) (Abstract and p77, left column). The hAMSC layer consists of a mixture of amniotic mesenchymal stromal cells (CD34+) and the mature mesenchymal stromal fibroblasts (CD34-). A minor fraction (less than 10%) of the mature mesenchymal stromal fibroblasts (CD34-) express CD117, CD133, CD146, CD201, SSEA-1, SSEA-3, and
Globo H as well (p78, right column). However, the CD34- mature mesenchymal stromal fibroblasts are not pluripotent stem cells, and only less than 10% of the CD34- mature mesenchymal stromal fibroblasts express CD133 and SSEA-3. Pavon et al. teach highly purified, neurosphere-forming CD133+ cells, obtained from human glioblastomas, express the cell marker profile characteristics of MSCs and the pluripotency markers, SSEA-1, Mush-1 and Nanog (p40547, right column). Pavon et al. teach flow cytometry analyses showed that the CD133+ cells highly expressed CD44 (94.0%) and CD90 (94.4%) (Figure 1D, 1E). In addition, a percentage of these cells also co-expressed CD44 and SSEA-3 (99.8%), as well as Mush-1 and Nanog (96.7%) (parag 40547, right column), the CD133+ cells did not express high levels of either HLA-DR or the hematopoietic and vascular cell markers CD14, CD31, CD34, CD45 and CD106 (parag 40547, right column). However, though the CD133+ glioblastoma cells express molecular signatures of MSCs, neural stem cells and pluripotent stem cells (see Abstract), they are not pluripotent stem cells which can form any cell type in the body. Therefore the claimed CD133-positive, SSEA-3 positive, and CD-34-negative pluripotent stem cells in instant claims are considered novel and art free.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/Q.G./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633