DETAILED ACTION
Claims 1, 3-8, 10, 17, 19-20 and 22-25 are currently pending. Claims 1, 3, 5-8, 10, 17, 19 and 22-25 are currently under examination.
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 .
Withdrawn Rejections
The prior rejection of claims 17 and 19 under 112 (b) is withdrawn based on Applicant’s claim amendments to specify the NrF2 inducer.
The prior rejection of claim(s) 1, 3, 5-7, 9-10, 17, 19, 22-23 and 25 under 35 U.S.C. 103 as being unpatentable over Kim in view of US 2014/0024713 is withdrawn in light of Applicant’s amendment to specify not administering another agent comprising a diuretic, a NSAID or a combination thereof, which Kim does not teach, as Kim requires administration of an NSAID having diuretic properties.
Examiner’s Note
Applicant's amendments and arguments filed 04/24/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04/24/2026, it is noted that claims 1, 17 and 19 have been amended and no new matter or claims have been added.
New Rejection:
The following rejections are newly added based on Applicant’s claim amendments.
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.
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) 1, 3, 5-8, 10, 17, 19, 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0024713 (previously applied) in view of Pazhayattil (Pazhayattil, Sunny et al, International Journal of Nephrology and Renovascular Disease 2014: 7, pgs. 457-468) as evidenced by PubChem (previously applied).
Regarding claims 1 and 5, the limitation of a method for treating nephrogenic disease in a subject comprising administering an affect amount of Nrf2 inducer and not administering another agent comprising a diuretic, a NSAID or a combination thereof, thereby treating the subject, wherein the NrF2 inducer is selected from a group including 10-nitrooctadec-9-enoic acid is met by the ‘713 publication teaching method of treating the side effects of a toxic medical therapy using nitrated lipids are disclosed. The methods comprise the use of nitrated fatty acids or esters thereof to treat side effects, including organ system damage caused by chemotherapy, radiotherapy and the administration of other toxic agents (abstract). The fatty acid is taught to be 10-nitrooleic acid [0006]. PubChem evidences 10-nitrooleic acid is a synonym for 10-nitrooctadec-9-enoic acid. Examples of topoisomerase inhibitors is taught to include lithium which encompass a toxic medical therapy ([0035]-[0037]) and wherein the side effects of toxic medical therapy includes organ system damage such as nephrotoxicity (kidney damage) ([0033], [0039], [0041]).
Regarding claim 3, the limitation of wherein the subject is human is met by the ‘713 publication teaching the subject is a human [0046].
Regarding claims 6-7, the limitation of wherein the NDI is lithium-induced NDI is met by the ‘713 publication teaching examples of topoisomerase inhibitors is taught to include lithium which encompass a toxic medical therapy ([0035]-[0037]) wherein toxic medical therapy is taught to include organ system damage which include nephrotoxicity (kidney damage and the like [0033]. Thus the ‘713 publication teaches administration of an effective amount of the active ingredient, thus teaching the active step and meeting the limitation of “preventing NDI” in a subject which was administered lithium.
Regarding claim 10, the limitation of wherein the method decreases the development of polyuria is met by the ‘713 publication teaches examples of topoisomerase inhibitors is taught to include lithium which encompass a toxic medical therapy ([0035]-[0037]). Thus the ‘713 publication teaches administration of an effective amount of the active ingredient, thus teaching the active step and meeting the limitation of “preventing polyurea”.
Regarding claims 17, 19, 22-25 is met by the ‘713 publication teaching the fatty acid is taught to be 10-nitrooleic acid [0006]. PubChem evidences 10-nitrooleic acid is a synonym for 10-nitrooctadec-9-enoic acid. The dose may be a single dose [0028] wherein the dose may be 1um to 1g per day [0043].
The ‘713 publication does not specifically teach treating nephrogenic diabetes insipidus (NDI) (claim 1) specifically acquired NDI (claim 5).
Pazhayattil teaches drug induced impairment of renal function (title). Nephrotoxic drugs are discussed and the clinical manifestations are discussed (abstract). Lithium has been the mainstay of treatment for patients with bipolar disorder for many years, reading on claim 8. Chronic lithium use can result in various forms of nephrotoxicity. The most common renal disorder associated with chronic lithium use is NDI. NDI can occur in up to 20% of patients on lithium. Lithium induced NDI is possibly by downregulation of AQP2 channels in the collecting duct. Lithium use has also resulted in hypercalcemia secondary to hyperparathyroidism (page 464, first column, last paragraph to second column, first paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the nitrofatty acids as taught by the ‘713 publication for the treatment of NDI as the ‘713 publication teaches the nitrofatty acids to be used to treat side effects of toxic medical therapy including lithium and nephrotoxicity and Pazhayattil teaches NDI is a result of lithium therapy. Thus it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use nitrofatty acids to treat NDI as the ‘713 publication teaches the connection between nitrofatty acid treatment, lithium induced damage and nephrotoxicity and Pazhayattil teaches NDI is a result of lithium induced nephrotoxicity. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘713 publication and Pazhayattil are both directed to lithium induced nephrotoxicity.
Response to Arguments:
Applicant’s arguments have been fully considered.
Applicant argues the claims have been amended to recite not administering another agent comprising a diuretic, non-steroidal anti-inflammatory agent or a combination thereof.
In response, as noted above the previously applied rejections have been withdrawn. Applicant is referred to the newly applied 103 rejection.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
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