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 17 March 2026. Claims 1, 4-6, 8, 10, and 13 have been amended. Claims 16-24 are newly added. Claims 2, 3, and 14 have been cancelled. The species other than a stabilizer in claim 20, and claims 22-23, are withdrawn as drawn to non-elected species. Claims 9-11, 13, and 15 remain withdrawn. Claims 1, 4-8, 16-21, and 24 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/JP2020/046355, filed 11 December 2020, which claims priority to Japanese patent document No. JP2019-224781, filed 12 December 2019.
Withdrawal of Rejections:
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 1-8 under 35 U.S.C. 103 as being unpatentable over Mitchell et al., in view of Wagner et al., is withdrawn.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, 4-8, 16-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Nishino et al. (US 2014/0227780; Published 2014), in view of Wagner et al. (US 2009/0035289; Published 2009 – Previously Presented).
With regard to claim 1, Nishino et al. teach a medium containing megakaryocytes and platelets produced by in vitro induced differentiation of pluripotent stem cells (Abs.), wherein megakaryocytes produced by in vitro induced differentiation of pluripotent stem cells are immortalized megakaryocytes.
While Nishino et al. teach that platelets have unstable storage stability, and that the medium containing the produced megakaryocytes and platelets can be stored using cryopreservation (Para. 69, 72), it is not specifically taught that the medium is freeze-dried.
Wagner et al. teach a freeze-dried platelet preparation, wherein freeze drying the preparation increases shelf-life (Abs.; Para. 3). Platelets have a short shelf life, and there is a need for a long-term storage solution that preserves their normal functions (Para. 3).
It would have been obvious to one of ordinary skill in the art to combine the teachings of Nishino et al. with Wagner et al., because both teach preparations containing platelets that are cryopreserved, and that platelets are unstable to store. It is known in the art from the teachings of Wagner et al. to provide a platelet-containing composition in freeze-dried form to extend shelf-life and maintain normal function. Utilizing freeze-drying as taught by Wagner et al. for the medium containing megakaryocytes and platelets of Nishino et al. amounts to the simple substitution of a cryopreserved medium generally, for a specific type of known cryopreservation, and would have been expected to predictably and successfully cryopreserve the medium of Nishino et al. as desired.
With regard to claims 4, Nishino et al. teach that the pluripotent stem cells are induced pluripotent stem cells (Para. 42).
With regard to claims 5, 6, and 24, taken together Nishino et al. and Wagner et al. render obvious the preparation as claimed, including the components as claimed. As the preparation cannot be separated from its properties and capabilities, the megakaryocytes and/or platelets present in the preparation are necessarily capable of providing the function of releasing a growth factor into the medium during culturing, which would subsequently be present in the freeze-dried preparation; the growth factor necessarily including bone morphogenetic proteins, platelet-derived growth factors, platelet-derived angiogenesis factors, transforming growth factors, vascular endothelial growth factors, epithelial growth factors, fibroblast growth factors, hepatocyte growth factors, platelet-derived endothelial cell growth factors, insulin-like growth factors, and platelet factor IV.
With regard to claim 7, taken together Nishino et al. and Wagner et al. render obvious the preparation as claimed, including the components as claimed. As the preparation cannot be separated from its properties and capabilities, the preparation is a pharmaceutical composition capable of providing the function of promoting bone adhesion, or treating or preventing a skin disease.
With regard to claims 8 and 16-18, Nishino et al. teach that the medium containing the megakaryocytes and platelets is useful for treatment of diseases characterized by a decrease in platelets, such as lysosomal storage diseases, blood cancers, and numerous other diseases and conditions including those that affect bone adhesion and the skin (Abs.; Para. 74-75). Wagner et al. teach that the freeze-dried preparation can include platelets in an amount of 9x105 cells/µl (Para. 66), where the freeze-dried preparation is effective for treating a wound, including a diabetic ulcer, or failed skin graft or flap (Para. 53), which is treating a skin disease. As such, it would have been obvious to one of ordinary skill in the art to utilize the combined preparation of Nishino et al. and Wagner et al. in an effective amount to treat a skin disease, as taught by Wagner et al.
Further, while a specific amount of each cell type in a ratio is not taught, it would have been routine for an ordinary artisan to determine the most appropriate concentration of the megakaryocytes and platelets in the formulation to treat the specific diseases indicated by Nishino et al. (see Para. 75). Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the amounts of the two active ingredients in the combined composition, including providing a ratio of 1x103 to 1x105 immortalized megakaryocytes to 1x106 platelets, 2x102 to 1.5x104 platelets to 1x103 immortalized megakaryocytes, and 3% or more megakaryocytes, to result in an effective amount of the cells in the formulation for the desired end use.
With regard to claims 19-21, Nishino et al. teach that GM6001, a broad-range hydroxamic acid-based metalloprotease inhibitor, is added to prevent platelet deactivation during cryopreservation and storage (Para. 72), wherein GM6001 is a stabilizer. GM6001 contains the amino acid tryptophan, and calcium chloride is present in the dilution buffer (see Art of Record: Millipore Sigma).
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.
Art of Record:
Millipore Sigma, GM6001 MMP Inhibitor Powder, Accessed 6/26/2026, Available online at: www.sigmaaldrich.com/US/en/product/mm/cc1100?srsltid=AfmBOopYKGzbMJZZJUepKvpMUPq7brwofplPexSWcT8A-p0OaCcuQ_TE (GM6001 contains the amino acid tryptophan and calcium chloride is present in the dilution buffer).
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.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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