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 .
1. Original claims 1-18 are pending and under examination.
Claim Objections
2. Applicant is advised that should claims 13-14 and 15 be found allowable, claims 16-17 and 18, respectively, will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
3. 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
4. Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maenhoudt et al. (Stem Cell Reports, 2020, 14: 717-729).
Maenhoudt et al. disclose a medium composition (OCOM4) comprising DMEM/F12, streptomycin, HGF, NRG1, and IGF1 (see supplemental Table S1).
The recitations “for use in preparing an intestinal organoid” in claim 1 and “wherein the intestinal organoid expresses” in claim 2 are only an intended use which does not state any distinct definition of any of the claimed limitations such as to differentiate the claimed composition from the composition disclosed by Maenhoudt et al. This intended use is of no significance to the composition structure and therefore, it is of no significance in claim construction.
Thus, Maenhoudt et al. disclose all claim limitations and anticipate the claimed invention.
Claim Rejections - 35 USC § 103
5. 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.
6. Claims 1-5 and 7-18 are rejected under 35 U.S.C. 103 as being unpatentable over Segeritz et al. (WO 18/218344), in view of Jardé at al. (Cell Stem Cell, 2020, 27: 646-662).
Segeritz et al. teach: (1) a method for producing an intestinal organoid by culturing intestinal cells isolated from a subject in a medium comprising Advanced DMEM/F12, HGF and EGF; (2) a pharmaceutical composition comprising the intestinal organoid; and (3) using the intestinal organoid for drug screening (claims 1-4, 7-13, 15, 16, and 18) (see [0019]; [0021]-[0022]; [0033]-[0034]; [0040]; [0087]; [0089]-[0090]; [0121]; [0130]; [0172]; [0184]; claims 1, 5, 12, and 24). With respect to claims 14 and 17, since Segeritz et al. teach using the intestinal organoid for drug screening, one of skill in the art would have found obvious to screen for drugs capable of treating intestinal diseases.
Segeritz et al. do not teach NRG1 (claim 1). Jardé at al. teach that NRG1 is superior to EGF in promoting the formation of intestinal organoids and can substitute for EGF (see paragraph bridging p. 647 and 649; p. 659, column 2, first full paragraph). Jardé at al. also teach including streptomycin in the organoid medium (claim 5) (see Methods, p. e4). Based on these teachings, one of skill in the art would have found obvious to modify Segeritz et al. by replacing EGF with NRG1 and adding streptomycin, to achieve the predictable result of increasing the efficiency of intestinal organoid formation.
The recitations “for preventing or treating an intestinal disease” (claim 9) and “wherein the intestinal disease is” (claims 10-12) are only an intended use which does not state any distinct definition of any of the claimed limitations such as to differentiate the claimed composition from the composition taught by the prior art. This intended use is of no significance to the composition structure and therefore, it is of no significance in claim construction.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
7. Claims 1-5 and 7-18 are rejected under 35 U.S.C. 103 as being unpatentable over Segeritz et al. taken with Jardé at al., in further view of Xu et al. (Theranostic, 2020, 10: 12204-12222).
The teachings of Segeritz et al. and Jardé at al. are applied as above for claims 1-5 and 7-18. Segeritz et al. and Jardé at al. do not teach IGF1 (claim 6). Xu et al. teach that IGF1 maintains the integrity of the intestinal epithelial cells and increases the number of intestinal organoids (see Abstract; paragraph bridging p. 12207 and 12208; p. 12216, column 1, last paragraph; Fig. 7E-F). One of skill in the art would have found obvious to modify Segeritz et al. and Jardé at al. by further adding IGF-1 to the culture medium, with the reasonable expectation that doing so would result in efficient intestinal organoid production.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
8. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/Primary Examiner, Art Unit 1633
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