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 .
Priority
This application is a 371 of PCT/US2022/012327 (01/13/2022)
PCT/US2022/012327 has PRO 63/137,524 (01/14/2021).
Status
Rejections not reiterated in this action are withdrawn.
Claims 1-17 are pending.
New Claim Rejections - 35 USC § 102
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bohne et al. (WO2018097733).
Bohne teaches “treatment of chronic fatigue syndrome (CFS)/ myalgia encephalomyelitis (ME)” by administering a therapeutic amount of a “composition comprising oxalate or oxalic acid, or a salt prodrug, derivative or metabolite thereof” (claim 1) where the oxalate is “oxaloacetic acid” (claim 3) administered as a tablet (p. 55-56). Thus, claim 1 is anticipated.
Regarding claims 2-3 specifying anhydrous enol-oxaloacetate, as evidenced by Cash (US20130143930, [0037]: “the solid form of oxaloacetic acid is primarily in the enol form”) the solid form taught by Bohne inherently teaches anhydrous enol-oxaloacetate.
Regarding claim 4 specifying the fatigue is associated with cancer in a subject, Bohne teaches CFS patients have cancer (p. 41).
Regarding claims 5-8, Bohne teaches administration of 610 mg oxalate (p. 52) administered as a tablet (p. 55-56).
Regarding claim 9 to a “method of treating fatigue associated with a disease in a subject, the method comprising administering a therapeutic amount of a compound to reverse metabolic dysfunction in the subject”, as with claim 1 administration of the oxaloacetic acid would also inherently result in reversing metabolic dysfunction in the subject. Regarding claims 10-17, as with claims 2-8, Bohne anticipates.
Double Patenting
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10016385. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are to a scope that includes methods of treating disease including cancer (claims 9-10) by administering oxaloacetate which would inherently treat associated fatigue and anticipates and renders obvious the instant claims.
Claims 1-3, 5-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11173139. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are to a scope that includes methods of treating Alzheimer’s disease by administering oxaloacetate which would inherently treat associated fatigue which anticipates and renders obvious the instant claims.
Conclusion
No claims allowed.
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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626