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 has PRO 63/420,932 (10/31/2022)
and PRO 63/400,384 (08/23/2022).
Status
Claims 1-11, 13-17 are pending.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11, 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fidalgo et al. (US20200087319).
Regarding claim 1, Fidalgo teaches pharmaceutical compounds for treating a receptor ([0008]: “treating a receptor-interacting protein kinase 1-mediated disease or disorder comprising administering a therapeutically effective amount of a compound or a pharmaceutical composition as described herein to a subject in need thereof.”; claims 49-50) including Example 29 (P. 63):
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Regarding claims 2-6, Fidalgo teaches dosing including ranges of 20 and 50 mg ([0424]-[0433]) and once and twice daily ([0430]: “the compositions thereof may be administered once, twice, three or four times daily”). Regarding claims 7-8, Fidalgo teaches administration orally ([0434]-[0435]) which one of skill in the art would at once envisage as both with and without food. Regarding claim 9, Fidalgo teaches continuous treatment ([0431]). Regarding claim 10, Fidalgo teaches administration of the compound with a carrier ([0429]) without reference to additional an therapy. Almirall, LLC v. Amneal Pharm., 28 F.4th 265, 273 (Fed. Cir. 2022) (“"[A] reference need not state a feature's absence in order to disclose a negative limitation." AC Techs., S.A. v. Amazon.com, Inc. , 912 F.3d 1358, 1367 (Fed. Cir. 2019).”). Regarding claim 11, Fidalgo teaches a human subject ([0045]). Regarding claim 13, Fidalgo teaches the disease or disorder treated includes amyotrophic lateral sclerosis ([0353], claims 49-50). Regarding claim 14 and 16, Fidalgo teaches administering a therapeutically effective amount including ranges of 20 mg ([0424]-[0433]) and once and twice daily ([0430]). Regarding claim 15 and 17, Fidalgo teaches the disease or disorder treated includes amyotrophic lateral sclerosis ([0353], claims 49-50).
With each of the above claims, one of skill in the art would at once envisage administering the same compound using a dosing schedule to the same disease in a manner such that the prior art anticipates the claim (MPEP 2131.02 III.).
Conclusion
No claims allowed.
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