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 .
Withdrawn Rejection
The rejection of claim(s) 1 and 4, as amended or previously presented, under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Studer (WO 2020/069515 A1 publication date:4/2/2020 and effectively filed:9/28/2018), is withdrawn. The amendments cancel these claims, rendering their rejection moot.
The objection to the drawings is withdrawn. The replacement drawing is discernable.
The rejection of claim(s) 1 and 4, under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Studer (WO 2020/069515 A1 publication date:4/2/2020 and effectively filed:9/28/2018), is withdrawn. Studer does not disclose wherein differentiated microglial are obtained within 30 to 40 days from initiation of preparing and culturing yok sac-mimic organoids from human pluripotent stem cells in an NGD medium comprising BMP4 and activin A.
The rejection of claim(s) 5-6 and 8-13, under 35 U.S.C. 103 as being unpatentable over Muffat (Muffat et al. Nature Medicine. 2016. 22(11):1358-1367 and online methods pp. 1-2. Of record in IDS 6/16/2022) in further view of Studer (WO 2020/069515 A1 publication date:4/2/2020 and effectively filed:9/28/2018), is withdrawn. Muffat does not teach differentiated microglial are obtained within 30 to 40 days from initiation of preparing and culturing yok sac-mimic organoids from human pluripotent stem cells in an NGD medium comprising BMP4 and activin A and there is nothing that would suggest that the addition of the method of Studer would arrive at microglial being obtained within 30 to 40 days as claimed.
Claim Rejections - 35 USC § 112/New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-6 and 8-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
When determining if a newly added recitation to a claim has sufficient written description, the breadth of the newly added recitation or amended claim comprising the newly added recitation is determined and the specification and claims, as originally filed, are examined to determine if they have at least one of explicit or implicit written description for the newly added recitation or amended claim.
Independent claim 5 newly recites, “wherein the differentiated microglia are obtained within 30 to 40 days from initiation of preparing and culturing yolk sac-mimic organoids from pluripotent stem cells in an NGD medium comprising BMP2 and activin A”. The newly added recitation narrows the scope of claimed method by limiting the amount of time in which microglia appear in the culture, particularly 30 to 40 days after the initiation of the preparing and culturing step. As such, the claim is fairly narrow in scope.
A search of the specification and claims, as originally filed, failed to provide a literal recitation of “wherein the differentiated microglia are obtained within 30 to 40 days from initiation of preparing and culturing yolk sac-mimic organoids from pluripotent stem cells in an NGD medium comprising BMP2 and activin A”. As such, the original disclosure does not provide explicit written description for the newly added recitation.
A review of the originally filed disclosure provides the following descriptions (citations are from the pre-grant publication):
[0051] By preparing yolk sac-mimic organoids from human pluripotent stem cells, that is, obtaining organoids containing the maximum amount of each target cells, patterning and proliferating the organoid tissue, and replacing the liquid medium with brain cell culture conditions during culture, it was confirmed that just as microglia penetrate into the brain at the actual development stage, after a certain culture period, in the CSF (cerebrospinal fluid) environment, only microglia efficiently escaped from the organoids into the culture solution by taking a strategy to change the culture conditions in the brain, and a large quantity of microglia having a high purity may be obtained. Since there is the proliferating cell population in the cell population that has escaped in this way, it is possible to continue to separate the microglia in about 30 to 40 days.
[0075] Specifically, mature microglia may be obtained in about 30 to 40 days. In particular, it is possible to produce cells 45 to 55 days earlier than in Non-Patent Document 1 and about 8 to 18 days earlier than in Non-Patent Document 2.
These two disclosures are the closest recitation to the newly added recitation. Applicant even refers to [0075] in their remarks as showing a demonstration that the claimed method is an improvement and unexpected finding over the prior art.
However, the newly added recitation, “wherein the differentiated microglia are obtained within 30 to 40 days from initiation of preparing and culturing yolk sac-mimic organoids from pluripotent stem cells in an NGD medium comprising BMP2 and activin A” is not commensurate in scope with the disclosures of the original specification and claims. The newly added recitation very specifically states, “obtained within 30 to 40 of initiation of preparing and culturing…”, whereas the original disclosure more open-endedly states that the microglia may be obtained in about 30 to 40 days but does not specify from time point the about 30 to 40 days is measured because it does not specify the initiation of preparing or culturing as claimed. As such, the newly added recitation is new adding a finite start point that was not stated or implicitly contemplated in the original disclosure. As such, the original specification and claims also do not provide sufficient implicit description for the newly added recitation.
In conclusion, the newly added recitation, “wherein the differentiated microglia are obtained within 30 to 40 days from initiation of preparing and culturing yolk sac-mimic organoids from pluripotent stem cells in an NGD medium comprising BMP2 and activin A” constitutes new matter because it narrows the scope of the disclosure in a way not expressly or implicit described by the original disclosure.
Claims 6 and 8-13 dependent upon claim 5. As such, they also comprise the above new matter.
Claim Objections
Claim 5 is objected to because of the following informalities:
In lines 5 and 12, it recites “an NGD”. This is grammatically incorrect. Amending this recitation to state, “a NGD”, would be remedial.
In line 7, it recites, “an N2 supplement medium”. This is grammatically incorrect. Amending this recitation to state. “a N2 supplement medium”, would be remedial.
Appropriate correction is required.
Claim 6 is objected to because of the following informalities: The claims appears to be specifying the timing (day 9 to day 11) for replacing the NGD medium. However, reciting “replaced with an N2 supplement medium” does not properly provide antecedent basis. Amending the recitation to state, “replaced with the N2 supplement medium”, would be remedial. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: The grammatical construction of this sentence is awkward. Amending the claim to recite, “The differentiation method according to claim 5, further comprising cryopreserving the differentiated microglial for storage of the microglial” would be remedial. Appropriate correction is required.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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