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 .
Applicant's amendments to the claims filed on 03-21-2024 have been received and entered. Claims 1-18 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, in the reply filed on 06-01-2026 is acknowledged.
Claims 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06-01-2026.
Claims 1-9 are under consideration.
Priority
This application is a 371 of PCT/KR2023/009357 filed on 07/04/2023 which claim priority from foreign application KOREA 10-2023-0024352 filed on 02/23/2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03-21-2024 are in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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.
Claims 1-9 are 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.
Claims 1 and 5 contain the trademark/trade name "B27", Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the component of the neuronal culture medium and, accordingly, the identification/description is indefinite. Appropriate correction is required.
Claims 2-4, 6-9 are included in the rejection because they directly or indirectly depend
from base claim. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (Cell Prolif. 2023;56:e13396., doi:10.1111/cpr.13396, published: 02 January 2023), and Kook et al (PLoS ONE 8(8): e71641. doi:10.1371/journal.pone.0071641, Published August 13, 2013) as evidenced by Hanna Lab Protocol (Herein after Hanna, Hanna Lab Protocol – Weizmann Institute of Science Ver. 2 - Last updated: 17/02/2016, https://www.weizmann.ac.il/molgen/hanna/sites/molgen.hanna/files/users/user52/HANNA-LAB-B22-B27-PROTOCOL-V3.pdf).
Regarding to claims 1-4, Wu et al teach “a chemically defined system supports two distinct types of stem cell from a single blastocyst and their self-assembly to generate blastoid” (Title). Wu et al teach that for ESCs derivation, individual ACL-blastoids were transferred onto a fibronectin-coated 24-well plate and cultured in 2i/L medium, which comprised N2-B27 basic medium with PD0325901 (1 μM, Miltenyi Biotec) (activator of the canonical Wnt signaling pathway), CHIR99021 (3 μM, Miltenyi Biotec) ((activator of the canonical Wnt signaling pathway)) and LIF (1000 IU/ml, Millipore) (Page 4, right column, 3rd para.).
Although Wu et al teach “TSCs basal medium composed of RPMI 1640 (Gibco) supplemented with …. 25 ng/ml recombinant human FGF4 (rhFGF4)…” (Page 4, right column, 4th para.), Wu et al do not teach using FGF4 for culturing ESCs (Embryonic Stem Cells). Kook et al cure the deficiency.
Kook et al teach that “fibroblast growth factor-4 enhances proliferation of mouse embryonic stem cells via activation of c-Jun signaling” (title). Kook et al stated that “Our present findings show that exogenous FGF4 addition stimulates proliferation of mESCs as well as hPDLSCs and mBMMSCs via the activation of MAPK-mediated signaling” (Page 2, left column, 2nd para.)
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Wu et al by using exogenous FGF4 addition stimulates proliferation of mESCs as taught by Kook et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Kook et al provide explicit advantage of stimulating proliferation of mESCs as well as hPDLSCs and mBMMSCs via the activation of MAPK-mediated signaling” (Page 2, left column, 2nd para.) and fibroblast growth factor-4 enhances proliferation of mouse embryonic stem cells via activation of c-Jun signaling (Title). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Kook et al were successful in using exogenous FGF4 to enhance proliferation of mESCs.
Regarding to claim 5, Wu et al teach N2-B27 basic medium (Page 4, right column, 3rd para.). As evidenced by Hanna, B27 contains corticosterone, progesterone, and T3 (triiodo-L-thyronine) (See page 1 of Hanna).
Regarding to claim 6, Wu et al teach 25 ng/ml recombinant human FGF4 (Page 4, right column, 4th para.). Kook et al teach stem cell proliferation assay with 50 ng/ml FGF4 (Page 2, right column, 5th para.), and mESCs cultured in the presence of 0 to 200 ng/ml FGF4 (Page 2, right column, 2nd para.). Thus, it is indicating that the concentration of FGF4 was recognized in the prior art to be a result-effective variable. A person of ordinary skill in the art would have been motivated to use different concentration of FGF4 a plurality of times out of the course of routine optimization, in order to enhances proliferation of stem cells.
Regarding to claim 7, Kook et al teach mESCs were cultured in Dulbecco’s modified Eagle’s medium (DMEM) supplemented with 5 ng/ml mouse leukemia inhibitory factor (LIF) (Page 2, left column, 4th para.).
Regarding to claim 8, Wu et al teach “CHIR99021 (3 μM, Miltenyi Biotec)” (Page 4, right column, 3rd para.).
Regarding to claim 9, Wu et al stated that “ medium test experiments, we found that the addition of Activin A, CHIR99021 and LIF (ACL medium) supported the establishment of two types of stem cells, ESCs (ACL-ESCs) and XEN-like (ACL-XEN) cells, from one blastocyst” (Page 3, left column, 2nd para).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA NHAT TRAN whose telephone number is (571)270-0201. The examiner can normally be reached M-F (9-5).
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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