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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, presently claims 1-11, in the reply filed on 6/29/2026. is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/29/2026.
Claims 1-11 are under consideration on the merits.
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 1-3, 5, 6, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (Neurochemistry International 112 (2018) 159e165; provided in the IDS dated 10/30/2025).
Liu teaches a method of treating murine subjects suffering from epilepsy, the method comprising intraperitoneally administering 10 mg/kg per day of edaravone (subheading 2.1), such as to induce Nrf2 activation (e.g. increase the expression) as measured by significant increases in Nrf2 mRNA and protein (Fig. 3C and 3C), anticipating claims 1-3 and 11. Liu teaches that edaravone administration significantly improves the number of CA1 and CA3 neurons in the hippocampus of epileptic rats (Fig. 1), anticipating claim 5.
Regarding the axonal regeneration/growth of claims 1 and 5, claim 9, and claim 10, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id; see M.P.E.P. § 2112. In this case, Liu teaches edaravone as set forth in claim 2 and a specific dosage of edaravone as set forth in claim 11 which is effective to activate Nrf2. Therefore and absent any showing to the contrary, the methods of Liu would necessarily and inherently meet the functional limitations of claims 1, 5, 9, and 10.
Claims 1-3, 5-7, and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CLINICS 2021;76:e3131, 7 pages; provided in the IDS dated 10/30/2025).
Li teaches a method of treating murine subjects suffering from traumatic brain injury (TBI), the method comprising intraperitoneal administration of either 1) 3 mg/kg twice every 12 hours edaravone, or 2) 0.5 mg/kg twice every 12 hours of a plasmid encoding for Nrf2 (page 2, subheading “Construction of TBI rat models and plasmids”), such as to enhance subject performance in spatial learning and memory (Fig. 4 for edaravone and Fig. 6 for the NRf2 plasmid), anticipating claims 1-3, 6, 7, and 11. Li teaches that edaravone administration activates Nrf2 as measured by an increased in protein expression (Fig. 5A).
Regarding the axonal regeneration/growth of claims 1 and 5, claim 9, and claim 10, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id; see M.P.E.P. § 2112. In this case, Li teaches edaravone as set forth in claim 2 and a specific dosage of edaravone as set forth in claim 11 which is effective to activate Nrf2. Similarly, Li teaches a specific dosage of a plasmid encoding for Nrf2 which activates Nrf2 as measured by the enhancement of subject performance in spatial learning and memory. Therefore and absent any showing to the contrary, the methods of Li would necessarily and inherently meet the functional limitations of claims 1, 5, 9, and 10.
Claims 1-7, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakase et al. (BMC Neurology (2011), 11:39, 7 pages; Reference U) as evidenced by Liu et al. (Neurochemistry International 112 (2018) 159e165; provided in the IDS dated 10/30/2025).
Nakase teaches treating subjects suffering acute ischemic stroke, the method comprising intravenous administration of 30 mg edaravone twice per day (page 2, subheading “Patients”), such as to enhance the rate of reduction of the infarct/lesion size as compared to control group (Fig. 1 and Table 2), anticipating claims 1-3, enhancing neuron survival of claim 5, and claims 6 and 7.
Regarding the axonal regeneration/growth of claims 1 and 5, claim 9, and claim 10, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id; see M.P.E.P. § 2112. In this case, Nakase teaches edaravone as set forth in claim 2 and a specific dosage of edaravone which is effective to activate Nrf2 as evidenced by Liu, as Liu teaches that administration of edaravone induces Nrf2 activation (e.g. increase the expression) as measured by significant increases in Nrf2 mRNA and protein (Fig. 3C and 3C). Therefore and absent any showing to the contrary, the methods of Nakase as evidenced by Liu would necessarily and inherently meet the functional limitations of claims 1, 5, 9, and 10.
Claims 1, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiong et al. (J Clin Invest. 2015;125(4):1433–1445; provided in the IDS dated 10/30/2025).
Xiong teaches a method of treating murine subjects suffering from photoreceptor degeneration (e.g. optic neuropathy; rd1 mice, rd10 mice, and Rho-/- mice), the method comprising subretinally administering 0.3 μl of an AAV vector encoding for Nrf2 (Fig. 4A; pages 1442-1443, subheadings “AAV vector construction and virus production” and “AAV injection”), such as to improve cone density as compared to GFP-sham treated mice (Fig. 4H and 4Q), anticipating claims 1, 7, and 8.
In a separate embodiment, Xiong teaches a method of prophylactically treating murine subjects suffering from optic nerve crush (e.g. optic neuropathy), the method comprising intravitreally administering 0.3 μl of an AAV vector encoding for Nrf2 is effective improve retinal ganglion cell (RGC) survival (page 1440, the paragraph spanning both columns; Figure 8)
Regarding the axonal regeneration/growth of claim 1, and claim 10, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id; see M.P.E.P. § 2112. In this case, Xiong teaches AAV-mediated overexpression of Nrf2 as set forth in claim 8 and a specific dosage of the AAV-Nrf2 vector which is effective to activate Nrf2 and improve cone density in subjects suffering from photoreceptor degeneration and improves RGC survival in a model of optic neuropathy (i.e. optic nerve crush). Therefore and absent any showing to the contrary, the methods of Xiong would necessarily and inherently meet the functional limitations of claims 1 and 10.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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