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 .
Claims 1-9 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 4-9, in the reply filed on 11-11-2025 is acknowledged.
Claims 1-3 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11-11-2025.
Claims 4-9 are under consideration.
Priority
This application is a 371 of PCT/KR2021/014414 filed on 10/15/2021 which claim priority from foreign application KR 10-2020-0134618 filed on 10/16/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03-23-2023 are in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
The term “selective” in line 6 of claim 1 should read “selected”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The base claim 4 recites the phrase “selecting organoids present in one or more specific brain regions depending on a purpose of using a mini-brain structure” is vague and indefinite because it appears to implicitly require isolating/cutting off cellular organoids/tissue from brain. However, the specification of the claimed invention stated that “the brain organoids are formed through self-organization, self-proliferation, and tissue-specific lineage differentiation after culturing induced pluripotent stem cells in a medium containing a signal transducer in an in vivo-like substrate environment.” (see para. [3], page 2 of the instant disclosure). The specification of the claimed invention does not provide guidance for isolating/cutting off cellular organoids/tissue from brain for generating a mini-brain structure. Also, there is no step of culturing and differentiating induced pluripotent stem cells recited in the claims. Therefore, it is unclear if the claimed method requires a step of isolating/cutting off organoids/tissue from brain or culturing /differentiating induced pluripotent stem cells into brain organoid.
Furthermore, the phrase “depending a purpose of using a mini-brain structure” is unclear because the claims do not specify how “using a mini-brain structure” can function as selecting criteria for the brain organoid or how the use of a mini-brain structure can be related to structure/function of the organoid.
The base claim 4 also recites the phrase “so that the organoids become close to each other”. The specification of the claimed invention does not define the distance between the organoids to be accepted as being “close to each other”.
Claim 6 recites the phrase “using a specific culture medium” which is vague and render the claim indefinite because it is unclear the specific culture medium is specific for what cells or purposes. The instant specification does not define what is/are included or excluded to be “specific medium”.
Claim 7 recites the phrase “a predetermined time”; however, the instant disclosure does not define the phrase “predetermined time”. It is unclear how long is the duration of “predetermined time” can encompass.
Claim 9 contains the trademark/trade name “Matrigel”, Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the component of the “combination inducer” and, accordingly, the identification/description is indefinite. Appropriate correction is required.
Claims 5, 8are included in the rejection because they directly or indirectly depend from the rejected claims. 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 4, 5, 6, 7, 8, 9 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Bagley et al (Nat Methods 14, 743–751 (2017), doi:10.1038/nmeth.4304, 10 MAY 2017).
Claim interpretation:
Claim 5 requires “a combination inducer”, and claim 9 specifies “the combination inducer comprises one or more selected from the group consisting of Matrigel, collagen, gelatin, and a brain extracellular matrix extracted from an animal brain tissue”. Thus, combination inducer is interpreted as matrigel, collagen, gelatin, or a brain extracellular matrix extracted from an animal brain tissue.
Regarding to claim 4, Bagley et al teach that “ Different brain regions can be cultured in vitro within 3D cerebral organoids, …… Here, we describe a coculture method combining brain regions of choice within one organoid tissue. By fusing organoids of dorsal and ventral forebrain identities, we generate a dorsal–ventral axis ….” (Abstract).
Bagley et al teach Cerebral organoid generation and fusion (see the first page of the Method, right column, 2nd and 3rd para. and Figure 2):
“The protocol for generating ventral and dorsal organoids and the characterization of cerebral organoid fusions was tested using a feeder-dependent hiPSC line ……. organoids were grown in 10 cm cell culture dishes containing 25 mL of differentiation medium, and after the first media exchange they were maintained on an orbital shaker with medium exchange every 5–7 d.” (see the first page of the Method, right column, 2nd para. ).
“To create organoid fusions, EBs were grown separately and individually patterned using either dorsalUnt, dorsalCycA, or ventral protocols as described above. During Matrigel embedding, two EBs were transferred into the same parafilm well and embedded in a single droplet (~30 µL) of Matrigel. The EBs were gently positioned as close together as possible using a 20 µL pipet tip to ensure the EBs would remain in close proximity within the middle of the solidified Matrigel droplet. The fusion process is very efficient, and it occurs within 1 week when EBs are positioned as close as possible. If EBs were not positioned close enough, then visible space remained between organoids 1 week after embedding. These ‘failed’ fusions were removed by aspiration. In addition, if the Matrigel droplet disassembled during the embedding process or during additional feedings before fusion had been completed, these organoids were also removed by aspiration.” (see the first page of the Method, right column, 3rd para. ).
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Regarding to claims 5 and 9, Bagley et al teach “two EBs were transferred into the same parafilm well and embedded in a single droplet (~30 µL) of Matrigel. The EBs were gently positioned as close together as possible using a 20 µL pipet tip to ensure the EBs would remain in close proximity within the middle of the solidified Matrigel droplet. The fusion process is very efficient, and it occurs within 1 week when EBs are positioned as close as possible” (see the first page of the Method, right column, 3rd para. )
Regarding to claim 6, Bagley et al teach “The protocol for generating ventral and dorsal organoids and the characterization of cerebral organoid fusions was tested using a feeder-dependent hiPSC line ……. organoids were grown in 10 cm cell culture dishes containing 25 mL of differentiation medium, and after the first media exchange they were maintained on an orbital shaker with medium exchange every 5–7 d.” (see the first page of the Method, right column, 2nd para. ).
Regarding to claim 7, Bagley et al teach “To create organoid fusions, EBs were grown separately and individually patterned using either dorsalUnt, dorsalCycA, or ventral protocols as described above. During Matrigel embedding, two EBs were transferred into the same parafilm well and embedded in a single droplet (~30 µL) of Matrigel ……The fusion process is very efficient, and it occurs within 1 week when EBs are positioned as close as possible” (see the first page of the Method, right column, 3rd para. ). Since the EBs are transferred and mix 1:1 as in Figure 2, the amount of two EBs are equally mixed.
Regarding to claim 8, Bagley et al teach “two EBs were transferred into the same parafilm well and embedded in a single droplet (~30 µL) of Matrigel. The EBs were gently positioned as close together as possible using a 20 µL pipet tip to ensure the EBs would remain in close proximity within the middle of the solidified Matrigel droplet. The fusion process is very efficient, and it occurs within 1 week when EBs are positioned as close as possible” (see the first page of the Method, right column, 3rd para.).
Thus, claims 4-9 are anticipated by Bagley et al.
Conclusion
No claim is allowed.
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/KHOA NHAT TRAN/ Examiner, Art Unit 1632
/PETER PARAS JR/ Supervisory Patent Examiner, Art Unit 1632