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 1/14/2026 has been entered. Newly amended Claims 1-2, 4-5, 10-17, 19, 26, 28-29, 32, and 35 are pending in the application. Claims 1-2, 4-5, 10-17, and 19 are withdrawn and Claims 26, 28-29, 32, and 35 are examined herein. are pending in the application. Applicant’s amendments to the Claims have overcome every rejection previously set forth in the Non-Final Office Action mailed 9/15/2025.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Objections
Claim 26 is objected to because at least the definitions of R1 and R6 contain seemingly identical groups in “carboxyl group” and “COOH”. One of the duplicate groups should be removed from each of the definitions that appear in the claims. Alternatively, applicant may submit on the record that the groups are distinct and explain the difference between the two groups.
Appropriate correction is required.
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 § 102
Claims 26, 28, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hageman (WO2006024545).
Hageman teaches administering PARP-1 inhibitors to treat diseases and disorders (Abstract). “Preferably, said disease or disorder involving chronic or acute inflammatory processes is chosen from the group of diseases or disorders consisting of diabetes” (Page 12). Preferred embodiments of the invention for treating diabetes include coumarin-3-carboxylic acid (Page 5). “More specific, the invention relates to the use of any of the PARP-1 inhibitor compounds described herein to inhibit the formation of advanced glycation end products (AGEs) in patients with diabetes, and thereby enhance the glucose metabolism via oxidative pathways”, requiring glucose uptake and thereby modulation of blood glucose (Page 12). All routes of administration as claimed are described by Hageman (Page 21, Line 34-Page 33, Line 3). Mice with hyperglycemia (associated with both Type 1 and Type 2 diabetes) and diabetes are also treated with PARP-1 inhibitors in an experimental diet, i.e., orally (Pages 34-35).
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 26, 28, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Hageman (WO2006024545) in view of Akbari (Inflammopharmacology (2018) 26:685–698).
Hageman teaches administering PARP-1 inhibitors to treat diseases and disorders (Abstract). “Preferably, said disease or disorder involving chronic or acute inflammatory processes is chosen from the group of diseases or disorders consisting of diabetes” (Page 12). Preferred embodiments of the invention for treating diabetes include coumarin-3-carboxylic acid (Page 5). “More specific, the invention relates to the use of any of the PARP-1 inhibitor compounds described herein to inhibit the formation of advanced glycation end products (AGEs) in patients with diabetes, and thereby enhance the glucose metabolism via oxidative pathways”, requiring glucose uptake and thereby modulation of blood glucose (Page 12). All routes of administration as claimed are described by Hageman (Page 21, Line 34-Page 33, Line 3). Mice with hyperglycemia (associated with both Type 1 and Type 2 diabetes) and diabetes are also treated with PARP-1 inhibitors in an experimental diet, i.e., orally (Pages 34-35).
Hageman further teaches a decrease in IL-6 production in diabetic patients upon administration of PARP inhibitors, but does not relate such findings to blood glucose levels (Fig 1).
Akbari teaches “chronic treatment with IL-6 induces insulin resistance [and] suppresses glucose transport” or uptake. Therefore, one administering the coumarin derivative to treat adverse effects of diabetes would reasonably expect to also modulate blood glucose levels via suppression of chronically elevated IL-6 cytokines as taught by Akbari before the effective filing date of the pending claims. One of skill in the art would expect success because elevated IL-6 cytokines induce insulin resistance and suppress glucose transport and Hageman teaches that the PARP inhibitors decrease IL-6 production in specifically diabetic patients.
Conclusion
No claim is allowable. Claims 26, 28, and 35 are rejected.
Claims 29 and 32 are 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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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627