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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/01/2026 has been entered.
Claims 1 and 14 have been amended. No claims have been newly added or newly canceled.
Claims 1, 4-6, 8, and 10-14 are currently pending.
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/04/2025.
Claims 1, 4-6, 8, 10-11 and 13-14 have been examined on their merits.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-6, 8, 10-11, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Buc-Caron (Neurobiology of Disease 1995-newly cited) in view of Muffat et al (US 2018/0179494-newly cited).
Regarding claims 1, 4-6, 8, 10-11, 13-14, Buc-Caron disclose a method of isolating and culturing a mixture of cells comprising neuroepithelial cells and neuroepithelial progenitor cells (cells that can be differentiated into microglia cells and thus microglia progenitors) from a neuroepithelial layer of a subject, wherein the subject is a fetus isolated from a uterus of a pregnant patient (pages 38-40, Methods, Results, primary cultures of human epithelial and neuroblastic cells). The cells are cultured for 2 passages (subcultured)(page 42 Figure 3) and frozen (stored) and thawed (page 39 column 2). These human progenitor cells proliferating in vitro have many potential applications in gene therapy of neurodegenerative diseases (abstract)
Buc-Caron do not specifically include a step of isolating microglia cells from the culture.
Muffat teach that generation of human microglia cells from stem cells could have high impact applications for human health, particularly in disease areas and that there is a need for generating human microglia cells (page 1 para 04). Muffat disclose that microglia cells express IBA-1, TMEM119 and P2RY12 (page 2 para 22) as well as CD11b (page 2 para 21, page 3 para 27). Microglia are described as having a ramified form and capable of phagocytosis (page 2 para 17, para 21-22, page 17 para 251) and suggest the use of FACS (fluorescent-activated cell sorting) for isolation (page 2 para 22, page 18 para 255, page 21 para 274). Muffat disclose that neuroepithelium can be used to obtain microglia (pages 17-18 para 254)
One of ordinary skill in the art would have been motivated to use the culture of Buc-Caron to differentiate and isolate microglia from the neuroepithelial cell mixture because Muffat teach and suggest that the generation of human microglia could have high impact applications for human health, particularly in disease areas and that there is a need for generating human microglia cells (page 1 para 04). One of ordinary skill in the art would have been motivated to use IBA-1, TMEM119, P2RY12, and CD11b expression to isolate microglia from the culture of Buc-Caron because Muffat teach and suggest that these are markers that microglia express and when they have been differentiated from neuroepithelium. One of ordinary skill in the art would have been motivated to use physical properties of phagocytosis, ramified form and FACS to isolate microglia because Muffatt teach and suggest that these are properties and techniques know to characterize microglia cells. One of ordinary skill in the art would have had a reasonable expectation of success because both Buc-Caron and Muffat are culturing and differentiating human fetal neuroepithelial cells for potential applications in gene therapy of neurodegenerative diseases.
Therefore, the combined teachings of Buc-Caron and Muffatt render obvious Applicant’s invention as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-6, 8, 10-11 and 13-14 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
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Butovsky et al., “Targeting Apolipoprotein E (APOE) in Neurologic Disease”, US 2017/0334977.
Butovsky disclose wherein microglia express IBA-1, TMEM119, and CD11b (page 3 para 31).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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