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 .
Status of Claims
Currently, claims 47, and 70-74 are pending and under consideration in the instant application. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant Application. Response to Applicant's arguments follow. Allowable subject matter is indicated at the end of the office action. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
Claims 47 and 70-74 are rejected under 35 U.S.C. 103 as being unpatentable over Weiner (Weiner et al; US 8,962,583) in view of Tazi (Tazi et al; US 2015/0361491), and Koukos (Koukos et al; Gastroenterology, vol 145, pages 842-852, 2013).
With regard to claim 47, Weiner teaches detection of decreased levels of miR-124 in neural biological samples (microglial cells) from patients with inflammatory disease compared to controls as well as administering a therapeutic miR-124 for treatment of the inflammatory disease (col 19; example 1; patented claims 1-5). With regard to claim 47 and 74, Weiner does not teach administration of ABX-464 to ulcerative colitis (UC, inflammatory disease) patients following detection of decreased expression of miR-124, however Koukos teaches that miR-124 expression was downregulated in UC patients as compared to controls (see abstract, page 843). Koukos teaches that miR-124 appears to regulate expression of STAT3, and that reduced levels of the miRNA appears to increase expression of STAT3 which could promote inflammation. Additionally, Tazi teaches administering ABX-464 to PBMC samples from patients with decreased levels of miR-124. With regard to claims 70-72, Tazi teaches to measure miR-124 in a different biological samples including blood, saliva, tissue biopsy, a plurality of samples from a clinical trial, etc (para 0128). With regard to claim 73, Tazi teaches a control sample can be from non-diseased members of a population (para 0133). Tazi establishes that upregulation of miR-124 reduced inflammation in an EAE rodent mode, and that administration of ABX-434 increased expression of miR-124 in PBMC’s from HIV samples that had decreased expression of miR-124. Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have administered ABX-464 in the method of treatment of Weiner, to UC patients with decreased expression of miR-124, as taught by Koukos, because Tazi teaches that miR-124 is reduced in activated microglia in EAE and intravenous administration of miR-124 inhibits development of lesions (para 0167) while treatment with the instantly claimed compounds in PBMCs from HIV patients increased expression of miR-124 (para 0225).
Response to Arguments
The response traverses the rejection. The response and the declaration under 37 CFR 1.132 by Julien Santo have been thoroughly and carefully considered. In so far as the response and declaration’s arguments are directed to “reduced” level of miR-124, presumably compared to a control reference value as set forth in claim 47, it is noted that the control population is not defined in claim 47, while dependent claim 73 encompasses the control reference value is from the patient. Accordingly, the claims are not commensurate in scope with the secondary considerations set forth in the response and declaration. However, the following claim would be allowable if presented:
An in vitro or ex vivo method of selecting and treating a patient with inflammatory bowel disease comprising:
a) detecting a reduced level of expression of miR-124 in a biological sample collected from the patient compared to the level of expression of miR-124 in a control population of non-diseased members,
b) selecting the patient for therapeutic treatment of the inflammatory bowel disease, and
c) administering the therapeutic treatment to the selected patient, wherein the therapeutic treatment includes ABX-464 of Formula I….
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682