DETAILED ACTION
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 .
It is noted that the amended claims are the first recitation of the combination of ALS or Alzheimer’s disease in combination with an inhibitor consisting of SEQ ID NO: 2.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deng et al. (Cerebral Cortex, April 2019;29: 1509–1519).
Deng et al. teach a composition comprising an anti-miR-214-3p antagomir, wherein the antagomir is 100% identical to instant SEQ ID NO: 2 (see page 1510). The antagomir was in a composition comprising phosphate buffered saline and the composition was injected into ventricles of mice (instant claim 1).
The instant claims is a compound claim and the cited reference is not required to teach the intended use of for treating Alzheimer’s disease or ALS. The intended use does not introduce any specific structural limitation to the composition.
Therefore, the claim is anticipated by Deng et al.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deng et al. (Cerebral Cortex, April 2019;29: 1509–1519), as applied to claim 1 above, further in view of Jia et al. (Molecular Brain (2019) 12:104, 1-11).
Deng et al. teaches that miR-214-3p targets β-Catenin mRNA and down regulates the expression of β-Catenin protein in vitro and in vivo (page 1512).
Deng et al. teaches: The miR-214 3p antagomir was given by i.c.v. injection into the third cerebral ventricle (80mg/mL, 2μL) (Supplementary Fig. 9a). After 48h, the distribution of miR-214-3p was determined with fluorescent in situ hybridization (page 1513).
Deng et al. teaches: These above findings indicate that antagomir-214-3p reverses the behaviors that related to major depression, and β-catenin expression plays an important role in this process (page 1514).
Deng et al. teaches: our results indicate that antagomir-214-3p may improve the deficit of synaptic plasticity via regulating cldn1 expression (page 1515).
Deng et al. teaches: our rescue experiment demonstrate that intranasally delivered antagomir-214-3p exerted antidepressant effects mainly through the upregulation of β-catenin expression in the mPFC (page 1518).
Deng et al. teaches: Most importantly, our study highlights that intranasal administration of antagomir-214-3p may also serve as a means for the treatment of MDD and other psychiatric disorders (page 1518). Selection of a mode of administration is routine in the art and would have been a matter of design choice (instant claims 17 and 18).
Therefore, Deng et al. teaches that antagomir-214-3p (identical to instant SEQ ID NO: 2) results in the upregulation of β-catenin expression. Although Deng et al. does not teach a method of treating Alzheimer’s disease via delivery of the pharmaceutical composition comprising the miR-214-3p antagomir, it would have been obvious to deliver the antagomir of Deng et al. in a pharmaceutical composition to treat Alzheimer’s disease because restoring Wnt/ β-catenin signaling was known to be a promising therapeutic strategy for Alzheimer’s disease, as taught by Jia et al. (title).
Therefore, one would reasonably expect that upregulating β-catenin would enhance synaptic plasticity and therefore treat Alzheimer’s disease because Jia et al. teach that Alzheimer’s brains experience synapse loss and that enhancing Wnt/ β-catenin signaling enhances synaptic plasticity (pages 2 and 3); and that Wnt/ β-catenin signaling is diminished in the Alzheimer’s brain (page 5) (instant claim 9).
Instant claims 19-22 recite intended outcomes rather than additional method steps and would therefore necessarily flow from the recited method step, delivery of a pharmaceutical composition consisting of instant SEQ ID NO: 2.
Conclusion
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 Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
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