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 .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7 June 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicants’ election of Group I (claims 1, 3, 6-7, 9, 12, 17-18, and 30-35) and Species of “enhancing expression” (claims 1, 6-7, 9, 12, 17, 18) in the reply filed on 8 April 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
It is noted that claim 18 is directed to “reducing expression or activity” which is a limitation found in withdrawn claim 3. It is believed that claim 18 should depend from claim 3 and is currently withdrawn for these reasons.
Status of Application
3. The instant claimed invention is a national stage entry of PCT/CN2022/136909 file 6 December 2022. Claims 1, 3, 6-7, 9, 12, 17-18, 20-24, 26, and 30-35 are currently pending. Claims 2, 4-5, 8, 10-11, 13-16, 19, 25, and 27-29 are cancelled. Claims 3, 18, 20-24, 26, and 30-35 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8 April 2026. Claims 1, 6-7, 9, 12, and 17 are examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b)
4. 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.
5. Claims 1, 6-7, 9, 12, and 17 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.
6. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation of “enhancing the expression or activity of miRNA”, and the claim also recites “preferably the expression or activity of the miRNA or lncRNA is enhanced through, for example, overexpression, gene activators, epigenetic modifications, miRNA mimics, direct delivery of RNA, small-molecule compounds and/or RNA stabilizers”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
7. Regarding claims 1, 7, and 17, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
8. Claim 6 recites the limitation "the miRNA selected from miR-7A, miR-15, miR-23a/b, miR-25, miR-29a, miR-129, miR-137, miR-138, miR-155, miR-195, miR-214, miR-222, miR-223, miR-132, miR-133" in line 4. There is insufficient antecedent basis for this limitation in the claim.
9. Claim 6 recites the limitation "the lncRNA selected from Pnky, Paupar, HOTAIRM1, lncR492, TUG1" in line 8. There is insufficient antecedent basis for this limitation in the claim.
10. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “wherein the glial cells are selected from astrocytes Glial cells, microglia, oligodendrocytes, ependymal cells, Schwann cells, NG2 cells, satellite cells or any combinations thereof”, and the claim also recites “preferably comprise astrocytes” and “preferably, wherein the glial cells are derived from brain, spinal cord, eyes or ears”, “more preferably are derived from striatum or substantia nigra” and “even more preferably the non-neuronal cells are glial cells” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
11. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation “neuronal cells”, and the claim also recites “preferably dopaminergic neurons, GABA neurons, 5-HT neurons…”, “more preferably are dopaminergic neurons” and “more preferably, the neuronal cells are dopaminergic neurons” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
12. Regarding claim 17, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
13. Regarding claim 17, the phrase "etc." renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
14. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “enhancing the expression or activity of the miRNA, lncRNA or a combination thereof” and “wherein it is preferable to express the miRNA or lncRNA or a combination thereof exogenously, for example, through an expression vector containing a promoter” which is the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections – 35 U.S.C. 103
15. 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.
16. Claim(s) 1, 6-7, 9, 12, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fu et al. (U.S. Patent Application Publication No. 2022/0364091) in view of Brodie et al. (U.S. Patent Application Publication No. 2015/0037299).
Fu et al. teach reprogramming a non-neuronal cell to a neuron. See abstract. The non-neuronal cell can be a glial cell that expresses miR-9 at a reduced level. The neuron is a dopaminergic neuron. See paragraph [0008]. The miR-9 agent increases miR-9 expression or activity. See paragraph [0006].
Fu et al. do not teach Let-7a.
Brodie et al. teach a method of predisposing mesenchymal stem cells (non-neuronal) to differentiate into neural stem cells by up-regulating a level of at least one exogenous miRNA such as miR-9. See claim 1. Brodie et al. also teach a method of predisposing neural stem cells to differentiate into motor neurons by up-regulating a level of at least one exogeneous miRNA selected from miR-Let-7a. See claim 10. Brodie et al. teach several studies have shown that MSCs following exposure to different factors in vitro, change their phenotype and demonstrate neuronal and glial markers. See paragraph [0006]. The neural stem cells of this aspect of the present invention may be non-committed neural stem cells that are not committed to any particular type of neural cell such as but not limited to neuronal and glial cell types. Preferably these cells have a potential to commit to a neural fate. Alternatively, the neural stem cells may be committed to a particular neural cell type, such as a motor neuron, but do not express/secrete markers of terminal differentiation, e.g. do not secrete neurotransmitters. See paragraph [0124].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one miRNA for another, in particular Let-7A, with a reasonable expectation of success, because Brodie et al. teach converting both non-neuronal to neural and neural to motor neurons by upregulating different miRNA through the use of miRNA such as Let-7A and miR-9 and Fu et al. teach the conversion of glial cells to dopaminergic neurons by enhancing expression of miR-9.
Conclusion
17. No claims are allowed at this time.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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