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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed August 18, 2026 and September 15, 2026.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/15/2026 has been entered.
Claims 1-12, 14-24, and 27-32 are pending in the application.
Claims 1-12 and 14-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/17/2025. No claims have been canceled, amended or newly added.
No claims have been amended, canceled or newly added as set forth in the claim set filed 08/18/2026.
The examiner acknowledges previously receiving an executed Declaration under 37 C.F.R. § 1.132 executed by Dr. Steven A. Goldman on April 7, 2026 (“Goldman Declaration”), and filed on 04/10/2026.
Therefore, claims 24 and 27-32 are examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed provisional application 63/378,092 filed 10/03/2022 and 63/274,763 filed 11/02/2021under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Thus, the earliest possible priority for the instant application is November 02, 2021.
Response to arguments
Withdrawn objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC§ 103
The rejection of claims 24 and 27-32 under 35 U.S.C. 103 as being unpatentable over Pol (Experimental Neurology, Volume 247, September 2013, Pages 694-702) in view of Ye (Nature Neuroscience volume 12, pages 829–838 (2009); IDS Reference) as evidenced by Megason (Development (2002) 129 (9): 2087–2098) and Zhang (Feb 2021, The Journal of Neuroscience, 41(8):1650–1664; IDS Reference) and Slutsky (Vol. 278, No. 11, Issue of March 14, pp. 8960–8968, 2003) is withdrawn.
Applicant’s arguments and amendments filed 09/15/2026 and 08/18/2026 have been considered. In light of the filing of a RCE, the references have been considered and Pol is no longer the primary reference utilized. A new rejection has been made to better address all limitations within the claims.
A response to Applicant’s arguments with regard to a withdrawn rejection is moot.
New objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 103
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.
Claims 24 and 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Goldman (WO; IDS Reference) in view of Li (Int J Clin Exp Med 2011;4(4):241-251)
Regarding claim 24, Goldman teaches a gene expression vector construct which comprises a nucleic acid which encodes TCFL72 as a modulator of glial cell differentiation under a Ef1a promoter (Claim 1, para. 0006, 0021, 0064, 0158).
However, Goldman does not teach that the promoter is a glial specific cell promoter.
Li teaches a PDGFRA promoter which has strong promoter activity in CG4, a rat brain-derived O-2A progenitor cell line (p. 245, 2nd column).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to have a construct encoding TCFL72 which comprises a PDGFRA promoter (i.e. glial specific promoter) with a reasonable expectation of success. An artisan would be motivated to utilize a glial specific promoter such as PDGFRA as it is shown that the promoter has strong activity in an O-2A progenitor cell Line and TCFL72 is utilized to modulate oligodendrocyte differentiation.
Regarding claim 27-28, the combination of Goldman and Li make obvious claim 24. Moreover, Goldman teaches that the modulators are packaged into a therapeutic expression vector such as denovirus vectors, adeno-associated virus vectors, retrovirus vectors, lentivirus vectors, or herpes virus vectors (para. 0064).
Regarding claims 29 and 30, the combination of Goldman and Li make obvious claim 24. The limitation of “administered to a subject with a glial progenitor cell-targeted fusogen or a glial cell progenitor cell-selective surface binding moiety” is an intended use or purpose for the construct. For product claims, intended purpose/use does not provide patentable weight unless it provides any structure limitation. See MPEP2111.02
Regarding claims 31, the combination of Goldman and Li make obvious claim 24. Moreover, Goldman teaches cells transfected with plasmid constructs (para. 0158).
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date.
Claims 32 are rejected under 35 U.S.C. 103 as being unpatentable over Goldman (WO; IDS Reference) in view of Li (Int J Clin Exp Med 2011;4(4):241-251) as applied to claim 24, and in further view of Pol (Experimental Neurology, Volume 247, September 2013, Pages 694-702)
As discussed above, the combination of Goldman and Li make obvious a construct with a PDGFRA promoter and a nucleic acid encoding TCFL72.
However, these references do not teach a glial specific enhancer.
Pol teaches a lentiviral vector comprising a nucleic acid molecule for a gene SOX10-MCS5 glial cell specific enhancer, which directs reporter expression to oligodendrocyte lineage cells in mouse and zebrafish (i.e. enhancer for a gene selectively or specifically expressed by glial progenitor cells) which dynamically identifies live human oligodendrocyte precursor cells (OPCs) (Abstract, Fig 1a).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to additionally include a glial specific enhancer as taught by Pol with the construct comprising a glial specific promoter as taught by Goldman and Li with a reasonable expectation of success. An artisan would have been motivated to do so as it would increase the selectivity of the vector to oligodendrocyte progenitor cells as Pol teaches constructs comprising such an enhancer dynamically identify live human oligodendrocyte precursor cells.
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA CONNORS whose telephone number is (571)272-7010. The examiner can normally be reached Monday - Friday (9AM-5PM).
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
