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 .
Priority
This application is a national stage entry under 35 USC 371 of PCT/JP2022/042210 (filed on 11/14/2022), which claims priority to JAPAN 2021-184912 (filed on 11/12/2021).
Claim Objections
Claims 9, 11,13, 15, 17, and 19 are objected to because of the following informalities:
Regarding claims 9, 11,13, 15, 17, and 19, recite ‘a period for’, it should recite ‘the period for’.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schlegel et al (US2013/0309681A1).
Schlegel et al disclosed methods of culturing non-keratinocyte epithelial (NKE) cells comprising NKE cells in the presence of feeder cells and a medium that inhibits Rho kinase (ROCK) (See, Abstract).
Regarding claims 8-11, Schlegel et al disclosed that the invention is to a method of culturing NKE cells in the presence of feeder cells, calcium-containing medium, and inhibiting ROCK in the feeder cell, the NKE cell or both (See, ¶0011).
Schlegel et al discloses in their claims that the non-keratinocyte epithelial cells can be large intestinal epithelial cells (See, p 17 claims 61 and 72). This reads on, culturing colorectal epithelial cells in the presence of ROCK inhibitor of claim 8, as large intestinal epithelial cells are colorectal epithelial cells.
Example 3 of Schlegel et al disclosed the use of ROCK inhibitor Y-27632 began when the cells were initially plated and continue thereafter. This reads on, where in the ROCK inhibitor is (1R,4r)-4-((R)-1-aminoethyl)-N-(pyridin-4-yl)cyclohexanecarboxamide, as this is the chemical formula for Y-27632 of claim 10 (See, SPEC ¶0010).
Figure 2 of Schlegel shows the cells were grown for 25 to 60 days depending on the cell type (See, ¶0125-0126). This reads on, wherein the period for the culture is 40 days or longer of claims 9 and 11.
Therefore, claims 8-11 are anticipated by Schlege et al.
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.
Claims 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Schlegel et al (US2013/0309681A1) as applied to claims 8-11 above, and further in view of Abdouh et al (Journal of experimental & clinical cancer research, 2019) and Kalluri & LeBleu (Science, 2020).
The teachings of Schlegel et al have been set forth above.
Regarding claims 12,14, and 18, Schlegel et al does not teach the isolation of extracellular vesicles from the culture supernatant.
Abdouh et al teaches a method of isolating extracellular vesicles (EVs) from a colon cancer cell line (HT29) and then exposing BRCA1- knock out (KO) fibroblasts to the isolated EVs. This resulted in a phenotypical change of the fibroblast to colon cancer cells (See, Abstract).
Abdouh et al teaches that the HT29 cells were cultured and the isolated EVs were measured to be 50 to 120 nm in diameter (See, p7 col 1 paragraph 4). Kalluri and LeBleu that teach that EVs are distinguished by their size and that exosomes are EVs within the size range of ~40-160nm in diameter with an average being 100nm (See, Abstract). This indicates that the extracellular vesicles in Abdouh are exosomes. This reads on, wherein the extracellular vesicles are exosomes of claims 14 and 18.
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of Schlegel et al to further comprise recovering the culture supernatant and isolating the EVs. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have been motivated to make this modification as, Kalluri and LeBleu teaches that exosomes have emerged as new diagnostic and treatment tool, therefore there are benefits to collecting and isolate exosomes. One would have had a reasonable expectation of success, evidenced by Abdouh et al.
Regarding claims 13,15,17, and 19, following the discussion above, Figure 2 of Schlegel shows the cells were grown for 25 to 60 days depending on the cell type (See, ¶0125-0126). This reads on, wherein the period for the culture is 28 days or longer of claims 13,15,17, and 19.
Regarding claim 16, following the discussion above, Example 3 of Schlegel et al disclosed the use of ROCK inhibitor Y-27632 began when the cells were initially plated and continue thereafter. This reads on, where in the ROCK inhibitor is (1R,4r)-4-((R)-1-aminoethyl)-N-(pyridin-4-yl)cyclohexanecarboxamide, as this is the chemical formula for Y-27632 of claim 16.
Therefore, claims 12-19 have been rendered obvious over Schlegel et al in view of Abdouh et al and Kalluri and LeBleu
Conclusion
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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