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 arguments and amendments filed on 3/19/2026 have been entered.
Claim 1 has been amended.
Claims 13-16 are new.
The 102 rejection of record has been amended to address the new limitation in claim 1 and claims 13, 15 and 16.
Claims 1-16 are examined in the instant application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-12 remain rejected and new claims 13, 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takashima et al. (WO 2019/093340, WIPO English Translation attached) for reasons of record in the Non-Final Office Action mailed on 11/5/2025 (and repeated as amended below).
Regarding claims 1-3, Takashima et al. teach a method of producing a pluripotent stem (PS) cell population comprising adherent culture of PS cells, while maintaining an undifferentiated state, in a liquid medium comprising 2-3 μM Go 6983 (a PKCβ inhibitor) and 2 μM XAV939 (a TNKS inhibitor);
and a step of suspension culture of the PS cells after adherent culture (parags. 23-25 and 54-57).
Regarding claim 4, Takashima teaches the liquid medium can comprise transferrin and insulin (parag. 23).
Regarding claim 5, Takashima teaches that the liquid medium can comprise a TGFβ inhibitor (parag. 23).
Regarding claims 6 and 7, Takashima teaches that the liquid medium can comprise Y-27632 (a ROCK inhibitor) (parag. 54).
Regarding claims 8 and 9, Takashima teaches that a cell aggregate is formed during suspension culture and then collected (parags. 25 and 37).
Regarding claim 10, Takashima teaches expressing OCT4, SOX2 and NANOG to obtain iPS cells, thus the pluripotent stem cells would all have an expression of 90% or higher (parag. 11).
Regarding claim 11, Takashima teaches that the cells are iPS cells (parag. 11).
Regarding claim 12, Takashima does not teach that the suspension culture comprises a PKCβ inhibitor and/or TNKS inhibitor (parags. 24 and 25).
Regarding claim 13, Takashima teaches that the cells can be directly adhered to the surface via an external matrix (parags. 24 and 26).
Regarding claim 15, Takashima teaches that the TNKS inhibitor can be IWR-1-endo (parag. 17).
Regarding claim 16, Takashima teaches that the external matrix can be laminin (parag. 26).
Thus the teachings of Takashima clearly anticipate the invention of claims 1-12, 13, 15 and 16.
Response to Arguments
While Applicant’s arguments have been fully considered they are not found persuasive. There is no requirement that a single example in Takashima teaches the claimed invention. Rather, Takashima teaches clearly that their method has flexibility in how it is performed, particularly to the combination and timing of factors used in culture (parag. 23), whether the adhesion culture is with an extracellular matrix (using a wide variety of matrix in parag. 26) or with a feeder layer (parag. 24) and the culture temperature (parag. 27). There is no improper hindsight reasoning required to apply the teachings of Takashima as prior art because teaches the two operable steps required, a step of adhesion culture comprising a PKCβ inhibitor and a TNKS inhibitor followed by a suspension culture. Applicant’s make the argument that it was surprising that adherent culture in the presence of the two claimed inhibitors prevented cell death of PSCs in a subsequent suspension culture step. However, his argument is not persuasive as there are no functional limitations regarding preventing cell death and further, Takashima teaches using the same claimed inhibitors, thus this observed surprising result would be inherent to the method of Takashima.
Thus, for the reasons above and of record the rejection is maintained.
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 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Takashima et al. (WO 2019/093340, WIPO English Translation attached) in view of Cohen et al. (2002, Nature Reviews, Drug Discovery, Vol. 1, pgs. 309-315).
Regarding claim 1, Takashima et al. teach a method of producing a pluripotent stem (PS) cell population comprising adherent culture of PS cells, while maintaining an undifferentiated state, in a liquid medium comprising 2-3 μM Go 6983 (a PKCβ inhibitor) and 2 μM XAV939 (a TNKS inhibitor);
and a step of suspension culture of the PS cells after adherent culture (parags. 23-25 and 54-57).
Takashima does not teach:
LY-333531.
Regarding the use of LY-333531 and claim 14, Cohen et al. teach that LY-
333531 is a potent PKCβ inhibitor, which is more potent against PKCβ than other isoforms (pg. 309, col. 3, last parag.).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Takashima regarding a method of producing a pluripotent stem cell population with the teachings of Cohen regarding LY-333531 to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to substitute the PKCβ inhibitor LY-333531 of Cohen for the PKCβ inhibitor XAV-939 of Takashima since Cohen teaches that LY-333531 is a potent inhibitor of PKCβ inhibitor.
There would have been a reasonable expectation of success that the LY-333531 of Cohen would work in the method of Takashima since Cohen teaches that the function of LY-333531 is to inhibit PKCβ.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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DAVID A. MONTANARI
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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