DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2 February 2026 has been entered.
Claim 1 has been amended. Claims 2-3 remain withdrawn. Claim 1 is currently pending and under examination.
The present application is a divisional of U.S. Patent Application No. 15/523746, filed May 2, 2017, which is the National Stage of International Application No. PCT/JP2015/081408, filed November 6, 2015, which claims benefit of priority to Japanese Application No. 2014-226682, filed November 7, 2014.
Withdrawal of Rejections:
The rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Tang et al., is withdrawn.
New Rejections:
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (US 2013/0028909; Published Jan. 31, 2013 – Previously presented), in view of Van de Donk et al., Brentuximab vedotin, Landes Bioscience, Vol. 4, Iss. 4, (July/August 2012), pp. 458-465 – Previously presented art of record).
With regard to claim 1, Tang et al. teach a method of producing a cell population including liver cells, which are differentiated cells, obtained by inducing differentiation of pluripotent stem cells in a culture medium, where the amount of undifferentiated stem cells in the population is reduced as compared to an amount prior to performance of the method (Abs.; Para. 41-43, 55). The method including culturing a mixed population of cells comprising differentiated cells and pluripotent cells, and depleting the pluripotent cells by affinity separation techniques, including utilizing antibodies and a cocktail of pluripotent markers, including CD30, and using a cytotoxic agent conjugated with an affinity reagent, which includes an antibody, bound to one or more markers, including CD30 (Para. 41, 45-47, 55). Which encompasses affinity separation using a cytotoxic agent, which is a drug having cell-killing activity, conjugated with a linker cleavable in an intracellular environment to an antibody bound to one or more markers including CD30, which is an anti-CD30 antibody.
Tang et al. do not specifically teach that the anti-CD30 antibody is used as a sole antibody-drug conjugate in the method.
Van de Donk et al. teach that Brentuximab vedotin is an anti-CD30 antibody conjugated via a protease-cleavable linker to a potent anti-microtubule agent, wherein binding to CD30-positive cells leads to cell cycle arrest and apoptosis (Abs.).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Tang et al. and Van de Donk et al., because both teach the use of an anti-CD30 antibody conjugated via a cleavable linker to a cell-killing agent, to bind to CD30+ cells and cause their destruction. The use of an anti-CD30 antibody as the sole antibody-drug conjugate to target and eliminate CD30+ cells is known in the art as taught by Van de Donk et al. Tang et al. teach that an anti-CD30 antibody-drug conjugate is one of the antibody-drug conjugates usable for eliminating CD30+ undifferentiated cells, and Van de Donk et al. teach that an anti-CD30 antibody can be used as the sole antibody-drug conjugate to eliminate CD30+ cells. As such, an ordinary artisan would have been motivated from the teachings of Van de Donk et al. to eliminate CD30+ cells, including the undifferentiated cells of Tang et al., using an anti-CD30 antibody as the sole antibody-drug conjugate. The use of a sole antibody-drug conjugate would have been expected to predictably and successfully eliminate undifferentiated CD30+ cells as desired by Tang et al., while also simplifying the method by using one antibody-drug conjugate to accomplish the desired goal of eliminating CD30+ cells from the mixed culture.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653