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 .
This Office Action is in response to the paper filed 24 November 2025. Claims 1, 29, and 48 have been amended. Claims 11, 25, 33, 44, and 53 have been cancelled. Claims 15-17, 19, 20, 22, 29, 30, 33, 37-40, 48-50, and 57-59 remain withdrawn. Claims 1-4, 6, and 7 are currently pending and under examination.
This application is a National Phase Application of PCT International Application No. PCT/US2021/020301, filed March 1, 2021; and claims benefit of priority to U.S. Patent Application No. 62/983120, filed February 28, 2020.
Withdrawal of Rejections:
The rejection of claims 1-4, 6, and 7 under 35 U.S.C. 102(a)(1) as being anticipated by Furue et al., is withdrawn.
The rejection of claims 1 and 11 under 35 U.S.C. 103 as being unpatentable over Furue et al., is withdrawn.
New Rejections Necessitated by Amendment:
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.
Claims 1-4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2017/171497; Published 2017 – US 2020/0297613, Published Sept. 24, 2020 is utilized as an English translation and referred to hereafter).
With regard to claim 1, Kim et al. teach a composition comprising a cell culture medium, the composition comprising collagen I (Para. 49-50), human albumin (Para. 42-44), L-glutamine (Para. 33-35), and NaHCO3 (Para. 33, 38-39). The collagen I is present in an amount including 1-200 µg/mL (Para. 49). The human albumin is present in an amount including 10-1000 µg/mL (Para. 44). The L-glutamine is present in an amount including 10 to 18 parts by weight (Para. 34). The NaHCO3 is present in an amount including 50 to 120 parts by weight (Para. 38). While the taught ranges are outside of those claimed, it would have been routine for an ordinary artisan to determine the appropriate concentration of each component in the cell culture medium in the composition based on the desired end use. Accordingly, one of ordinary skill in the art before the effective filing date would have optimized, by routine experimentation, the concentration of the collagen I, human albumin, L-glutamine, and NaHCO3 to obtain a cell culture medium with the desired properties for the end use. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Kim et al. render obvious the composition as claimed, including the components as claimed. As the composition cannot be separated from its function, the composition as rendered obvious by Kim et al. is necessarily capable of performing the function of facilitating the survival and engraftment of cells for transplantation.
With regard to claims 2-4, 6, and 7, Kim et al. render obvious the composition as claimed, including the components as claimed. As the composition cannot be separated from its function, the composition as rendered obvious by Kim et al. is necessarily capable of performing the function of facilitating the survival and engraftment of cells for transplantation, the cells including: human or non-human animal cells; β-cells of pancreatic islets, including human, murine, porcine, or stem cell-derived β-cells; endocrine and/or secretory cells including hepatocytes, parathyroid cells, and adrenal gland cells, and the endocrine cells including alpha cells or stem cell-derived endocrine cells.
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.
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653