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 .
Applicant's election without traverse of Group I, claims 1, 4, 5, 8, 9, 13, 16, 19, and 23, and the species of an agent that inhibits GPR17 and an agent that ablates and/or inhibits an activated microglia, in the reply filed on 1 October 2025 is acknowledged. Upon further search and consideration, the species of an agent that inhibits GPR17 and/or an agent that ablates and/or inhibits an activated microglia, is rejoined and examined on the merits.
Claims 22, 24, 26-28, 30-32, 42, 43, and 45, and the non-elected species in claims 1, 5, and 8, have been withdrawn. Claims 1, 4, 5, 8, 9, 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.
Claim Objections
Claim 1 is objected to because of the following informalities: the comma in front of “thereby” on the last line of this claim should be removed, as a semicolon was added right before. Additionally in claim 1, there should be a comma or semicolon following “microglia” on line 5. Appropriate correction is required.
Applicant is advised that should claim 4 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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.
Claims 1, 4, 5, 9, 13, 16, 19, and 23 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.
The term “agent that inhibits GPR17” in claim 1 is a relative term which renders the claim indefinite. The term “inhibits” 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. No definition or guidance is provided to indicate what level of inhibition is intended to be required for an agent to be included in, or excluded from, an agent that inhibits GPR17 as claimed.
Similarly, the term “agent that … inhibits an activated microglia” in claim 1 is a relative term which renders the claim indefinite. The term “inhibits” 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. No definition or guidance is provided to indicate what level of inhibition is intended to be required for an agent to be included in, or excluded from, an agent that inhibits an activated microglia as claimed.
Additionally in claim 1, the use of the phrase "and/or" multiple times is indefinite, because it creates multiple alternatives and, thus, it is uncertain what is intended for the method of increasing myelination of an axon.
The term “increases OPC number and/or differentiation” in claims 4, 9, and 23 is a relative term which renders the claim indefinite. The term “increases” 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. As no beginning or control OPC number or amount of differentiation is recited, it is unclear how an “increase” would be determined.
Claim 5 recites the limitation " the agent that ablates or inhibits an activated microglia" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “an agent that ablates and/or inhibits an activated microglia” (emphasis added), however, there is no agent previously recited that only ablates or inhibits an activated microglia.
Additionally, claim 5 recites in relevant part, “the agent that ablates or inhibits an activated microglia is PLX3397; the agent that ablates or inhibits an activated microglia is PLX3397”; this limitation is indefinite, because it is unclear if this limitation is intentionally repeated twice, and if so, how the second recitation is intended to provide a limitation different from the first.
Claim 13 recites that “the agents are administered concurrently or sequentially.” This claim is indefinite, because claim 1 does not require more than one agent to be present. The species under examination is “an agent that inhibits GPR17 and/or an agent that ablates and/or inhibits an activated microglia”; while more than one agent may be used, only one agent is required. Claim 13 as currently presented does not further require more than one agent to be present. As such, it is unclear how one agent may be administered concurrently or sequentially with itself.
Likewise, claims 16 and 19 recite that “the agents” are administered. These claims are indefinite, because as noted only a single agent is required per claim 1. Thus, it is unclear what additional agent is being referred to by the plural “the agents.”
Further with regard to claim 19, the term “for at least between 14 and 28 days” is indefinite, because the metes and bounds of the phrase “for at least between” are unclear. The limitations of “for at least” and “between” are mutually exclusive as currently used. As such, the administration timeframe is unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 8, 9, 13, 16, 19, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tait et al. (US 2019/0336490; Published Nov. 7, 2019).
With regard to claims 1 and 8, 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.
With regard to claims 4, 9, and 23, Tait et al. teach that the method provides the results of inducing or increasing OPC differentiation (Para. 112), which is increasing OPC number and/or differentiation, including in a subject.
With regard to claim 13, as noted above, this claim is indefinite. As Tait et al. teach that the MAChR antagonist/inverse agonist/partial agonist, which includes clemastine, may be administered sequentially or simultaneously with an additional agent (Para. 601), this limitation is deemed to be met.
With regard to claim 16, as noted above, this claim is indefinite. Tait et al. teach that the MAChR antagonist/inverse agonist/partial agonist, which includes 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 include administering the agent concurrent with or subsequent to injury, or prior to injury.
With regard to claim 19, as noted above, this claim is indefinite. As Tait et al. teach that the clemastine is administered for 7 days (Para. 797), the limitation as claimed is deemed to be met.
Claims 1, 4, 5, 8, 9, 13, 16, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franklin et al. (WO 2019/206419; Published October 31, 2019).
With regard to claims 1, 5, and 8, 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.
With regard to claims 4, 9, and 23, Franklin et al. teach that the method provides the results of promoting OPC differentiation (Abs.), which is increasing OPC number and/or differentiation, including in a subject.
With regard to claim 13, as noted above, this claim is indefinite. As Franklin et al. teach that the therapeutic combination as described may be administered concurrently or sequentially with another therapeutic agent (p. 8, line 28-31), this limitation is deemed to be met.
With regard to claim 16, as noted above, this claim is indefinite. Franklin et al. teach that the treatment is administered to delay the onset of a demyelinating disease, or reduce or halt the rate of progress of a demyelinating disease (p. 8, line 4-10), which include administering the treatment concurrent with or subsequent to injury, or prior to injury.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653