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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 24, 27-31, 34 and newly added claims 40-42) in the reply filed on Nov. 11, 2025 is acknowledged.
The restriction requirement is deemed proper and is therefore made FINAL.
Claims 1, 2, 5-7, 10-14, 36 and 39 are withdrawn. Claims 24, 27-31 are previously presented. Claim 34 has been newly amended. Claims 40-42 have been newly added.
Claims 24, 27-31, 34, and 40-42 are examined on their merits below.
Priority
The application claims priority to provisional application 63/086866, filed Oct. 20, 2020; as such the earliest possible priority date is Oct. 20, 2020.
Information Disclosure Statement
The information disclosure statements filed Mar. 31, 2023 and Oct. 20, 2023 and one filed on May 1, 2025 (citing 50 references) are in compliance with the provisions of 37 CFR 1.97. Accordingly, these IDSs have been considered by the examiner.
The information disclosure statements filed on May 1, 2025 (the seventeen (17) filed after the first one that was considered; Aug. 11, 2025; Oct. 31, 2025; Dec. 12, 2025; and Jan. 23, 2026 fail to comply with the provisions of 37 CFR 1.97(a) because they lack the appropriate size fee* set forth in 37 CFR 1.17(v). They have been placed in the application file, but the information referred to therein has not been considered as to the merits.
*Please note that while the size fee assertion and size fees for this case only apply to IDSs that were filed after Jan. 19, 2025, the number of references for the size assertion fee and the appropriate size fees are cumulative. Therefore, the first IDS that was filed on May 1, 2025 (citing 50 references) was correct in asserting that no size fee was required. However, the additional 17 references filed on May 1, 2025 and the IDS filed after this on Aug. 11, 2025; Oct. 31, 2025; Dec. 12, 2025; and Jan. 23, 2026 have additional size fees that are required, and at least some of them will need to be marked as requiring a size fee (determined by assessing the cumulative amount of references that are over 50).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 24, 27-30 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Chua et al. (Nature Cell Bio, 2014, cited in IDS filed on March 31, 2023) in view of Takebe et al. (WO 2020/023245 A1, cited in IDS filed on March 31, 2023).
The claims are directed to a composite organoid including a mesenchyme including mesenchymal cells isolated as mono-dissociated cells from a first organoid and an epithelium including epithelial cells isolated as an epithelial structure from a second organoid or enteroid.
With respect to independent claim 24, Chua et al. teach a composite organoid with mesenchyme from isolated mesenchymal cell and an epithelium including epithelial cells isolating from an epithelial structure from an organoid.
Chua et al. does not teach the mesenchymal cells are isolated from an organoid, rather teaching they are isolated from rat embryos.
Takebe et al. teach production of composite organoids including obtaining mono-dissociated mesenchymal cells that are isolated from multi-tissue spheroids (Abstract, Fig. 1, para. [0006].
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Chua et al. to incorporate using mesenchymal cells that are isolated from an organoid (as taught by Takebe et al.) because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating this modification would have led to predictable results with a reasonable expectation of success because both references are directed to heterogenous organoid production and making this modification would enable the composite organoid to use only human cells (in place of the rat cells), enabling production of a wholly human cell-derived organoid.
With respect claim 34 (which recites the method of making the product of claim 24), Chua et al. teach a method of producing a composite organoid including obtaining mono-dissociated mesenchymal cells (rat) and obtaining a prostate epithelial structure (CARN-derived organoids), mixing the two and co-culturing them to obtain a composite prostate organoid having an epithelial structure and mesenchyme cells (See pg. 952, “Results”; pg. 953, Fig. 1; Methods).
With respect to dependent claims 27-30, it would have been an obvious design modification to have tissue types of the first and second organoids be the same or different, depending on what type of screening the composite organoid was being used for, to enable the results of the screening to more closely parallel in vivo conditions. As different organoids are known in the art, the recombining of different types to product mesenchyme-free epithelial structure is a known objection by one of ordinary skill the in the art.
Claim(s) 31, and 40-42 rejected under 35 U.S.C. 103 as being unpatentable over Chua et al. (Nature Cell Bio, 2014, cited in IDS filed on March 31, 2023) and Takebe et al. (WO 2020/023245 A1, cited in IDS filed on March 31, 2023) as applied to claims 24, 27-30 and 34 above, and further in view of McCracken et al. (Nature, 2014, cited in IDS filed on May 1, 2025).
Chua et al. does not teach the mesenchyme is from gastric tissue and the epithelium is from intestinal tissue.
McCracken et al. teach human PSC-derived gastric organoids containing complex epithelium with glandular architecture and surrounding mesenchymal cells, indicating that this presents a new opportunity for drug discovery and modeling early stages of gastric disease, including cancer. (entire doc.)
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the organoid taught by Chua et al. to incorporate translating the concept to a gastric/intestinal model and using pluripotent stem cells (as taught by McCracken et al.) because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating this modification would have led to predictable results with a reasonable expectation of success because both Chua et al. and McCracken et al. are directed to organoids used in drug screening and modeling disease. It further would have been obvious to incorporate using intestinal epithelium, as doing so would enable modeling of certain types of gastric or intestinal cancers. Additionally, it would have been obvious to use induced pluripotent stem cells, as they provide a renewable source of material for generating the organoids, allowing scale up.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634