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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/13/2026 has been entered.
Withdrawn Rejections
The rejection of the claims under 112a are withdrawn in response to the amendments.
The rejection of claim 5 under 112b is withdrawn in response to the amendments.
Priority
This application, Serial No. 17/266,029 was filed on 02/04/2021, and is a 35 U.S.C. 371 national stage entry of PCT Application No. PCT/JP2019/031328 filed on 08/08/2019. Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) based on an application filed in Japan on 08/08/2018. Acknowledgement is also made of the English translation filed 09/03/2024 of the application filed in Japan on 08/08/2018.
Status of the Claims
Claims 1, 3-5 and 7-20 are pending; claims 1, 3-5 and 7-8 are amended, claims 9-20 are withdrawn. Claims 1, 3-5 and 7-8 are examined below.
Claim Rejections - 35 USC § 102
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 1, 3-5 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vlachogiannis et al., Science 359, 920–926 (2018) DOI: 10.1126/science.aao2774 (“Valeri”) as evidenced by Vlachogiannis et al. "Supplementary Materials for Patient-derived organoids model treatment response of metastatic gastrointestinal cancers" Published 23 February 2018, Science 359, 920 (2018) DOI: 10.1126/science.aao2774 (“Valeri-Supplemental”).
Regarding claims 1 and 5, Valeri teaches a culture method (“Patient Derived Organoids model treatment response of metastatic gastrointestinal cancers” Title). Note that as evidenced by Valeri-Supplemental, the Supplemental Materials of the Valeri reference which contain the Materials and Methods section, the patient-derived organoids are cultured (“Establishment and culture of PDOs from GI cancers” page 4). Valeri further teaches that wherein the method comprises: a step of three-dimensionally culturing organoids (Title). Note that as evidenced by Valeri-Supplemental, the organoids are three-dimensionally cultured (“Dissociated cells…resuspended in 120 μl of growth factor reduced (GFR) matrigel (Corning), and seeded in a well of a 24- or 48-well flat bottom cell culture plate (Corning). The matrigel was then solidified” page 4 para. 2). Note that although Valeri-Supplemental fails to use the language “three-dimensionally culturing”, the teaching of using a solid Matrigel as ECM for the culture of the cells inherently provides a 3D culture. Valeri further teaches the organoids being derived from cancer stem cells, wherein the cancer stem cells are derived from colorectal cancer, wherein the cancer stem cells were first treated with at least one anticancer agent, wherein the at least one anticancer agent is one or more anticancer agents that inhibit the growth of cancer cells (“We report on a living biobank of PDOs from metastatic, heavily pretreated colorectal and gastroesophageal cancer patients recruited in phase 1/2 clinical trials” Abstract, “PDOs presented in this study were derived from ultrasound (n = 20), computed tomography (CT)–guided (n = 7), or endoscopic (n = 2) biopsies of metastatic CRC (mCRC; n = 16), metastatic GOC (mGOC; n = 4), and metastatic cholangiocarcinoma (n = 1) patients (fig. S1). Liver, pelvic, peritoneal, and nodal metastases of chemo-refractory patients were used to establish PDOs” page 1 col. 3 para. 2). Note that although Valeri fails to use the language “derived from cancer stem cells, wherein the cancer stem cells are derived from colorectal cancer, wherein the cancer stem cells were first treated with at least one anticancer agent”, the teaching of using biopsies of chemo-refractory metastasis of colorectal cancer inherently provides the organoid being derived from colorectal cancer stem cells that were first treated with an anticancer agent because the tumor in the colorectal cancer patients are expected to contain colorectal cancer stem cells and since the patient is ”chemo-refractory” the tumor has also been treated with at least one anticancer agent. Note that the specification teaches that chemo-refractory tumors contain cancer stem cells (“As for the reason for resistance, it is assumed that anticancer agent treatment induces a group of cells that have acquired resistance and that manage to survive. However, regarding the origin of cells that acquire resistance, several different theories such as cancer stem cells (CSC) and epithelial mesenchymal transition (EMT) have been advocated” para. 3). Therefore, Valeri inherently teaches the organoids being derived from cancer stem cells, wherein the cancer stem cells are derived from colorectal cancer, wherein the cancer stem cells were first treated with at least one anticancer agent. Furthermore, although Valeri fails to use the language “wherein the at least one anticancer agent is one or more anticancer agents that inhibit the growth of cancer cells”, the teaching of the chemotherapy drugs used in the patients inherently provides the inhibiting of the growth of cancer cells. Note also that table s1 of Valeri contains the information of the chemotherapy agents used in the patients. Table s1 of Valeri has been included in the Valeri-Supplemental reference. As evidenced by Valeri-Supplemental, one of the anticancer agents used was, for example, “Oxaliplatin” (page 48), therefore this anticancer agent inherently provides the inhibiting of the growth of cancer cells (“oxaliplatin” para. 21 of instant spec.). Valeri further teaches a step of recovering the organoids from the three-dimensional culture (Title). Note that as evidenced by Valeri-Supplemental the 3D culture of the organoids involves a step of recovering the organoids from the three-dimensional culture (“Passaging of PDOs was performed using TrypLe. Briefly, PDOs were mechanically harvested (pipetting) out of matrigel” page 4 para. 3). Note that although Valeri-Supplemental fails to use the language “recovering the organoids”, the teaching of harvesting the organoids inherently provides a step of recovering the organoids.
Regarding claims 3 and 7, Valeri further teaches wherein the three-dimensional culturing step comprises allowing the organoids derived from colorectal cancer stem cells previously treated with the at least one anticancer agent to adhere to a first extracellular matrix and culturing by adding a first medium (Title). Note that as evidenced by Valeri-Supplemental, the organoids are allowed to adhere to a first extracellular matrix and are cultured by adding a first medium (“resuspended in 120 μl of growth factor reduced (GFR) matrigel (Corning), and seeded in a well of a 24- or 48-well flat bottom cell culture plate (Corning). The matrigel was then solidified by a 20-minute incubation in a 37 oC and 5% CO2 cell culture incubator, and overlaid with 500 μl of complete human organoid media” page 4 para. 2).
Regarding claims 4 and 8, Valeri further teaches wherein the organoids derived from colorectal cancer stem cells are formed by a pre-culture step of culturing one or more cancer stem cells (Title). Note that as evidenced by Valeri-Supplemental, the organoids are formed by a preculture step of culturing one or more cancer stem cells (“Biopsies were minced … Dissociated cells were collected … resuspended in 120 μl of growth factor reduced (GFR) matrigel (Corning), and seeded in a well of a 24- or 48-well flat bottom cell culture plate (Corning). The matrigel was then solidified by a 20-minute incubation in a 37 oC and 5% CO2 cell culture incubator, and overlaid with 500 μl of complete human organoid media; complete media was subsequently refreshed every two days” page 4 para. 2). Although Valeri-Supplemental fails to use the language “formed by a preculture step of culturing one or more cancer stem cells”, the teaching of seeding biopsy cells on matrigel and changing the media every two days inherently provides the organoids being formed by a pre-culture step of culturing one or more cancer stem cells because the biopsy cells contain cancer stem cells and the organoids are formed as time passes (pre-culture step).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-5 and 7-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FERNANDO IVICH whose telephone number is (703)756-5386. The examiner can normally be reached M-F 9:30-6:00 (E.T.).
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/Fernando Ivich/Examiner, Art Unit 1678
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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