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 7 August 2025. Claims 1, 3-6, and 8 have been amended. Claims 2 and 9-20 have been cancelled. Claims 1 and 3-8 are currently pending and under examination.
This application is a U.S. National Phase of International PCT Application No.
PCT/US2020/056624, filed October 21, 2020, which claims the benefit of U.S. Provisional Application No. 62/923,886, filed October 21, 2019.
Withdrawal of Rejections:
The rejection of claims 1-10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Xiang et al., is withdrawn.
The rejection of claims 1-10 under 35 U.S.C. 103 as being unpatentable over Xiang et al., in view of Pasca, is withdrawn.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 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Schröder et al. (WO 2015/135893; Published 2015 – English translation provided by Examiner and referred to hereafter).
Regarding claims 1 and 3, Schröder et al. teach a three-dimensional cerebral organoid, which is a three-dimensional neural tissue composition comprising an assembloid, the cerebral organoid comprising three-dimensional cell aggregates, comprising two, three, or more regions corresponding to different brain regions, including the retina, cortex, and thalamus, which are organoids, fused together to create a neural network (p. 4, para. 5-10). As Schröder et al. specifically teach that the assembloid comprises two or more region-specific organoids including the retina, cortex, and thalamus, it would have been obvious to one of ordinary skill in the art to provide an assembloid comprising a retinal organoid, a cortical organoid, and a thalamic organoid that are operatively fused to form the assembloid, as each or these regions are taught and may be present in the overall structure.
With regard to claims 4 and 5, while the organization of the fused organoids is not specifically taught, as Schröder et al. teach that the assembloid comprises three or more organoids that are fused to create a neural network, the organoids including a retinal organoid, a cortical organoid, and a thalamic organoid, it would have been obvious to one of ordinary skill in the art that each of the taught organoids could be directly fused to each other as desired for the end use. Including fusing the cortical organoid directly to the retinal organoid, and fusing the thalamic organoid directly to the retinal organoid; or fusing a first end of the thalamic organoid to the retinal organoid, and fusing a second end of the thalamic organoid to the cortical organoid, thus providing an assembloid having the appropriate structure for the desired end use.
With regard to claims 6 and 7, taken together, Schröder et al. render obvious the composition as claimed, including the components as claimed. As the components cannot be separated from their properties, the retinal organoid would necessarily further comprise one or more retinal ganglion cells residing in the retinal organoid, wherein when the retinal organoid is in use, the present retinal ganglion cells would necessarily provide the function of having axons extending beyond the retinal organoid, including into the thalamic organoid and/or the cortical organoid. Thus, forming the connected neural network as desired by Schröder et al. (p. 4, para. 5-10).
With regard to claim 8, taken together, Schröder et al. render obvious the composition as claimed, including the components as claimed. As the components cannot be separated from their properties, the thalamic organoid would necessarily further comprise one or more thalamic cells, wherein when the thalamic organoid is in use, the present thalamic cells would necessarily provide the function of migrating into the other present organoids, including the retinal organoid. Thus, forming the connected neural network as desired by Schröder et al. (p. 4, para. 5-10).
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.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653