DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 21 April 2026. Claims 1, 4, 5, 19, and 23 have been amended. Claims 8 and 9 have been cancelled. Claims 22, 24, 26-28, 30-32, 42, 43, and 45, and the non-elected species in claims 1 and 5 remain withdrawn. Claims 1, 4, 5, 13, 16, 19, and 23 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/US2021/029806, filed April 29, 2021, which claims priority to U.S. Provisional Application No. 63/018939 filed May 1, 2020.
Withdrawal of Objections/Rejections:
The objection to claim 1 and claim 9, is withdrawn.
The rejection of claims 1, 4, 5, 9, 13, 16, 19, and 23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 1, 4, 8, 9, 13, 16, 19, and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Tait et al., is withdrawn.
The rejection of claims 1, 4, 5, 8, 9, 13, 16, and 23 under 35 U.S.C. 102(a)(1) as being anticipated by Franklin et al., is withdrawn.
New Rejections Necessitated by Amendment:
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.
Claims 1, 4, 5, 13, 16, 19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Tait et al. (US 2019/0336490; Published Nov. 7, 2019 – Previously Presented), in view of Franklin et al. (WO 2019/206419; Published October 31, 2019 – Previously Presented).
With regard to claims 1 and 5, Tait et al. teach a method of increasing myelination of an axon by increasing proliferation of oligodendrocyte progenitor cells (OPCs) into mature, myelinating oligodendrocytes, the method comprising contacting neural tissue containing OPCs, including a neuronal axon, with an agent having MAChR antagonist/inverse agonist/partial agonist activity (Abs.; 106, 111-116), the agent including clemastine (Para. 13), which is an agent that inhibits an activated microglia. Thus, Tait et al. teach a method of increasing myelination of an axon by contacting an OPC in the presence of an axon with clemastine, thereby increasing myelination of the axon.
Tait et al. do not teach that the neural tissue containing OPCs are also contacted with an agent that inhibits GPR17.
Franklin et al. teach a method of increasing remyelination of neuronal axons, the method comprising contacting oligodendrocyte progenitor cells (OPCs), which are in the presence of the neuronal axons needing remyelination, with an AMPK agonist and a differentiation factor, the differentiation factor including GPR17 antagonists including Montelukast or Pranlukast, thereby increasing remyelination of the neuronal axons (Abs.; p. 5, line 5-15; claims 1-4). Thus, Franklin et al. teach a method of increasing myelination of an axon by contacting an OPC in the presence of an axon with Montelukast or Pranlukast, thereby increasing myelination of the axon.
It would have been obvious to one of ordinary skill in the art to combine the teachings of Tait et al. and Franklin et al., because both teach methods for increasing myelination of an axon. Increasing myelination of an axon by contacting an OPC in the presence of an axon with GPR17 antagonists including Montelukast or Pranlukast, is known in the art as taught by Franklin et al. Contacting the OPCs of Tait et al. in the presence of an axon, with GPR17 antagonists including Montelukast or Pranlukast as taught by Franklin et al., would have been expected to predictably improve the method, by providing an additional agent also known to facilitate an increase in myelination of axons as desired.
With regard to claims 4 and 23, taken together, Tait et al. and Franklin et al. render obvious the method as claimed, including the agents as claimed. As such, performance of the method of Tait et al. and Franklin et al. would necessarily provide the results of increasing OPC number and/or differentiation, including in a subject, as compared to an untreated control.
With regard to claim 13, taken together, Tait et al. and Franklin et al. render obvious the method of increasing myelination of an axon by contacting OPCs in the presence of an axon with an agent that inhibits GPR17 and an agent that inhibits an activated microglia. It would have been routine for an ordinary artisan to determine the appropriate sequence for contacting the OPCs with each of the taught agents, including contacting the OPCs either sequentially or simultaneously.
With regard to claim 16, Tait et al. teach that the clemastine may be administered to increase remyelination and reduce symptoms of a demyelination disease (Para. 601-602), or for preventing a demyelination disorder in a subject (Para. 734), which includes administering the agent concurrent with or subsequent to injury, or prior to injury.
With regard to claim 19, Tait et al. teach that the clemastine is administered for 7 days (Para. 797). Taken together, Tait et al. and Franklin et al. render obvious the method as claimed, including the agents as claimed. It would have been routine for an ordinary artisan to determine the appropriate amount of time for administering the agents in the combined method based on the needs of the specific subject to be treated. Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the length of administration of the agents, including from 14-28 days, to result in the administration of an effective amount of the agents for the specific subject being treated when practicing the combined method.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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