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 .
DETAILED ACTION
Response to Amendment
The amendment filed 11/18/2025 has been entered. Newly amended Claims 1-2, 5, 11, 17-19, 22-23, 25, 28-31, 33-34, 37, 46, and 58-63 are pending in the application. Applicant’s amendments to the claims have overcome the rejection previously set forth in the Non-Final Office Action mailed 8/28/2025.
Claims 29-30, 33-34, 37, 46, and 60-63 are withdrawn as being drawn to an unelected invention. Claims 1-2, 5, 11, 17-19, 22-23, 25, 28, 31, and 58-59 are examined on the merits herein.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Applicant’s amendments to the claims render all rejections thereto moot.
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.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 5, 11, 17-19, 22-23, 25, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Labelle (WO2014053491, cited in 4/12/2022 IDS).
Labelle teaches Compound 58 as an HDME inhibitor (Abstract; Page 63):
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This compound is excepted by the proviso described in Claim 1.
Labelle, however, teaches acceptable modifications to compounds of the following Labelle formula:
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(Page 24, Lines 20+). Labelle teaches that the methoxy substituted aryl may be substituted by “one or more substituents” including alkoxy. Labelle therefore provides guidance for adding further methoxy substituents on the aryl. The Labelle compound can be present in pharmaceutical compositions (Abstract).
One of skill in the art seeking to design an HDME inhibitor before the filing date of the instant claims would find it obvious to add a second methoxy to the ring to Compound 58 as suggested by Labelle to yield a compound encompassed by instant Formula (I). The artisan would expect a successful HDME inhibitor to result because Labelle teaches both the compound and generic formula encompassing the modified compound as inhibitors of HDME, and the homologues are of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Claims 1-2, 5, 11, 17-19, 22-23, 25, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Labelle (WO2014053491, cited in 4/12/2022 IDS).
Labelle teaches Compound 85 as an HDME inhibitor (Abstract; Page 63):
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This compound is excepted by the proviso described in Claim 1.
Labelle, however, teaches acceptable modifications to compounds of the following Labelle formula:
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(Page 24, Lines 20+). Labelle teaches Y can be
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, wherein R10 and R11 are C1-6 alkyl (Page 14). Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09. The Labelle compound can be present in pharmaceutical compositions (Abstract).
One of skill in the art seeking to design an HDME inhibitor before the filing date of the instant claims would find it obvious to form methylene homologues of Compound 58 as suggested by Labelle to yield a compound encompassed by instant Formula (I) wherein instant R1B and either of R2 can be methyl, ethyl, or linear propyl and thus not excepted by applicant’s proviso. The artisan would expect a successful HDME inhibitor to result because Labelle teaches both the lead compound and generic formula encompassing the modified compounds as inhibitors of HDME, and the homologues are of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.
Conclusion
Claims 1-2, 5, 11, 17-19, 22-23, 25, and 31 are rejected. Claims 58-59 are allowable. Claim 28 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 extension fee 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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