-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 .
This action is in response to the papers filed October 17, 2025.
Applicant’s election without traverse of Group II (Claims 24-25 and 27-31) in the reply filed on 10/17/2025 is acknowledged.
Claims 1-12 and 14-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Therefore, claims 24-25 and 27-31 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.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
For example, there is no copy or IDS submitted for the multiple references listed in para. 0005 of the instant specification.
Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 24-25 and 27-31 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.
Claim 24 recites “and/or” in lines 4 and 6. It is unclear as to what the metes and bounds of this term are, as “and” could be interpreted to include only a promoter or only and enhancer, or all promoters and enhancers, or, “or” would imply that the promoter and enhancer are in the alternative.
Claims 24 and 25 recite the phrase “a gene selectively or specifically expressed by glial progenitor cells”. The term " selectively or specifically " in claims 24 and 25 renders the claim indefinite. The term " selectively or specifically " is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear if the genes expressed by glial progenitor cells result from transcriptional activation of a tissue specific promoter or enhancer, the genes are unique to glial progenitor cells, and others. Appropriate action is required.
Claim 29 recites that the gene construct “is in association with” a fusogen or moiety. It is unclear as to what the metes and bounds of this term are as an “association” could either be physically in a composition, or mental association. If the gene construct or composition comprising the construct further comprises a fusogen or moiety, it should be reflected in the claims as such.
Appropriate correction is required.
As independent claim 24 is indefinite, all subsequent dependent claims and independent claim 31 which encompasses the same limitation are additionally rejected as being indefinite.
Therefore, claims 24-25 and 27-31 are rejected as being indefinite.
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 24-25 and 27-31 are rejected 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).
Regarding claims 24 and 25, Pol teaches a lentiviral vector with a SOX10 enhancer known as MCS5, 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). Pol teaches Sox10-MCS5 reporter GFP expression in human fetal brain cells (Abstract, Fig 1a).
PNG
media_image1.png
417
787
media_image1.png
Greyscale
However, Pol does not teach a nucleic acid molecule encoding the TCF7L2.
Ye teaches an expression vector called pCIG comprising a gene construct which has a nucleic acid molecule encoding a transcription factor 7-like 2 protein (TCF7L2; TCF4) (Online Methods). As evidenced by Fig 1a of Megason (reference 50 of Ye) below, the pCIG expression vector comprises a beta actin promoter.
PNG
media_image2.png
238
372
media_image2.png
Greyscale
Ye further identifies TCF7L2 as being an oligodendrocyte lineage–specific transcription factor and Pdgfra and NG2 as oligodendrocyte precursor cell (OPC) markers (p. 837, 1st column; p. 830, 2nd column). The instant specification describes examples of glial precursor cells as oligodendrocyte precursor/progenitor cells (para. 0070).
Moreover, Zhang teaches promoting oligodendrocyte (OL) differentiation represents a promising option for remyelination therapy for treating the demyelinating disease multiple sclerosis (MS) and that TCF7L2 has a mechanism which promotes OL differentiation by repressing autocrine BMP4 signaling. (Abstract, p. 1650)
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to substitute a nucleic acid encoding TCF7L2 as taught by Ye for nucleic acid encoding a GFP of Pol with a reasonable expectation of success. An artisan would have been motivated to do so as Ye and Zhang teach that expression of TCF7L2 promotes OL differentiation which leads to a promising option for remyelination therapy.
Regarding claims 27 and 28, the combination of Pol, Ye and Zhang render obvious claim 24. Moreover, Pol teaches the vector utilized is a lentiviral vector (Abstract, Fig 1a).
Regarding claims 29 and 30, the combination of Pol, Ye and Zhang render obvious claim 24. The limitation “in association with a glial progenitor cell-selective surface-binding moiety” is interpreted to be associated with or related to. As Pol teaches such moieties like CD140a in the human OPCs targeted by the SOX10 enhancer (Abstract, p. 695, 1st column), it is determined in Pol’s genetic construct is “in association” with CD140a.
Regarding claims 31, the combination of Pol, Ye and Zhang render obvious claim 24. Moreover, Pol teaches the vector within OPCs (i.e. host cell, see instant specification para. 105) (Abstract, Fig 1a).
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA LEAVITT can be reached on (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634