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 .
Claims 1, 8, 9, 12, 14, 18, 20, and 27 have undergone amendments. Claims 2-7, 11, 17, and 21 have been cancelled. Claims 31-39 are newly added. Thus, Claims 1, 8-10, 12-14, 18-20, 27, and 31-39, submitted on 29 December 2025, represent all claims currently under consideration.
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.
Response to Amendment
The objection to Claim 1 is withdrawn. Applicant has corrected the misspelling of “independently”.
The 35 U.S.C. § 103 rejection of Claims 1-5, 7, 9-14, and 17-20 over Sotomayor in view of Blackburn is withdrawn. Applicant has amended Claim 1 to recite the limitations of Claim 6, which was not rejected over these references, and Claims 2-5, 7, 11, and 17 have been cancelled, rendering those rejections moot.
The 35 U.S.C. § 103 rejection of Claims 1-5, 7, 9, 11-13, and 17 over Tavares in view of Blackburn is withdrawn. Applicant has amended Claim 1 to recite the limitations of Claim 6, which was not rejected over these references, Claims 2-5, 7, 11, and 17 have been cancelled, rendering those rejections moot.
The 35 U.S.C. § 103 rejection of Claims 1-5, 7, 9-14, 17-20, and 27 over Sotomayor in view of Villagra is withdrawn. Applicant has amended Claim 1 to recite the limitations of Claim 6, which was not rejected over these references, and Claims 2-5, 7, 11, 17, and 21 have been cancelled, rendering those rejections moot.
The 35 U.S.C. § 103 rejection of Claims 1-5, 7, 9, 11-14, and 17-21 over Sotomayor in view of Blackburn and Awad is withdrawn. Applicant has amended Claim 1 to recite the limitations of Claim 6, which was not rejected over these references, and Claims 2-5, 7, 11, 17, and 21 have been cancelled, rendering those rejections moot.
The non-statutory double patenting rejection of Claims 1-5 and 7 over U.S. Patent No. 9,751,832 in view of Blackburn is withdrawn. Applicant has amended Claim 1 to recite the limitations of Claim 6, which was not rejected over these references, and Claims 2-5, and 7 have been cancelled, rendering those rejections moot.
Claim Rejections - 35 USC § 112(b)- NEW GROUNDS OF REJECTION
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims are indefinite as they are directed towards methods and compositions which utilize the compound of Claim 8 (emphasis added). There are multiple compounds claimed in Claim 8, causing there to be indefiniteness related to which compound is to be used to practice these methods and compositions. The Examiner suggests amending the claims to read “a compound of Claim 8”, or claiming a specific compound in the claims, to overcome the rejections.
Allowable Subject Matter
Claims 1, 8-10, 12-14, 18-20, and 27 are allowed.
Claims 31-39 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: No prior art was retrieved which anticipates or renders the compounds of newly amended Claim 1 obvious, and no art was retrieved which anticipates or renders the compounds of Claim 8 obvious (See Updated STN Search, Search Notes). The closest prior art comes from Sotomayor (US Patent No. 9,751,832). Sotomayor teaches compounds which inhibit HDAC6, as well as methods of their use for the treatment of cancers. However, none of the compounds provided as examples contain an -NH2 moiety on the phenyl ring. In view of the compounds disclosed by Sotomayor, the artisan would not be motivated to modify the compounds which are disclosed to include this moiety as Sotomayor has not provided evidence that this moiety is conducive to the inhibition of HDAC6, leading to no reasonable expectation of success. Olarte (WO 2006/013209; Publication Date: 9 February 2006) discloses inhibitors of copper-containing amine oxidases and their use in the treatment of inflammatory diseases, atherosclerosis, neurodegenerative disease, obesity, hypertension, and cancer (Abstract). One compound which is disclosed is 4-[[[[(2-aminophenyl)amino]carbonyl]amino]methyl]-N-hydroxy-benzamide
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which does contain an NH2 moiety on the phenyl ring. However, this is not linked with a carbon atom to the ring, nor is there any alkyl chain which comes off of the nitrogen atoms linking the two phenyl groups. Further, these compounds are not HDAC6 inhibitors, and there is no indication that these compounds can be used to inhibit HDAC6, as they are described as inhibitors of copper-containing amine oxidases, with no data provided indicating that they would function in inhibiting HDAC6. Thus, there is no teaching, suggestion, or motivation found within this disclosure that would lead one of ordinary skill in the art to modify these compounds for use as HDAC6 inhibitors.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1, 8-10, 12-14, 18-20, and 27 are allowed.
Claims 31-39 are rejected.
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 PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625