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 .
Status of Claims
Claims 1, 3 – 6, and 9 – 19 are currently pending. Claims 1 and 9 have been amended in the Applicant’s amendment filed September 3, 2025. Claims 12 – 19 have been added in the Applicant’s amended filed September 3, 2025. No claims have been canceled in the Applicant’s amendment filed September 3, 2025.
Applicant’s election without traverse of Group I, claims 1, 2 and 9, drawn to a method of expanding a primordial germ cell (PGC) or pluripotent stem cell-derived primordial germ cell like cell (PGCLC), in the presence of phosphodiesterase 4 (PDE4) and cyclosporine A was previously acknowledged.
Claims 3 – 6 and 10 – 11 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Therefore, claims 1, 9, and 12 - 19 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed May 29, 2020, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2018/045011, filed November 30, 2018, which claims the benefit of
Japanese Patent Application 2017-231294, filed November 30, 2017.
Therefore, the earliest priority date is 30 November, 2017.
Withdrawn Objections /Rejections
Claim Rejections - 35 USC § 112(a) - Written Description
The rejection of claim 9 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or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention is withdrawn.
The Applicant has convinced the Examiner that the as-Filed Specification does teach the limitations of claim 9. Particularly, the Applicant notes that the PGCLCs amplified with FR10 + CsA showed the same gene expression as PGCLCs amplified by only FR10. Example III only teaches that the PGCLCs amplified in the presence of FR10 to yield oocytes. Thus, one or ordinary skill in the art would expect that these PGCLCs if amplified in the presence of FR10 and cyclosporine would also yield oocytes.
In view of the withdrawn rejection, Applicant’s arguments are moot.
Claim Rejection - 35 USC § 112(a) Scope of Enablement
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.
The rejection of claims 1 and 9 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn.
Claim 1 has been amended to include the specific concentrations of forskolin, rolipram, and cyclosporine A.
Dependent claims of claim 9 have been added to include the specific concentrations of BMP and RA.
In view of the withdrawn rejection, Applicant’s arguments are moot.
New Objections /Rejections
Claim Rejection - 35 USC § 112(b)
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 15 and 19 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. This is a new rejection necessitated by the response file September 3, 2025.
Claims 15 and 19 are indefinite for the recitation of “PGCLC is produced via an EpiLC” such as recited in line 5. It is unclear how a cell can be produced from another cell, and how the cell can be produced “via” another cell. Thus, the metes and bounds of the claim cannot be determined.
Claims 15 and 19 are indefinite for the recitation of “PGCLC is a cell on d4-d10, wherein the day of start of differentiation induction from EpiLC is d0” such as recited in claim 15 line 6 – 7. It is unclear what the d4-d10 is referring to, whether that refers to embryonic age, differentiation age ESCs or another metric. Thus, the metes and bounds of the claim cannot be determined.
Conclusion
Claims 1, 9, 12 – 14, and 16 – 18 are allowed.
Claims 15 and 19 are rejected.
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHUBHAM TIWARI whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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/VYOMA SHUBHAM TIWARI/Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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