DETAILED ACTION
Claims 1, 3-10, 17, 19-20 and 22-25 are pending. Claims 1, 3, 5-10, 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/13/2025 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 08/13/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 08/13/2025, it is noted that claim 1 has been amended and no new matter or claims have been added.
New Rejections:
The following rejections has been newly added based on Applicant’s claim amendments.
Claim Objections
Claim 17 is objected to because of the following informalities: Claim 17 contains the limitation “wherein the nitro fatty acid administered at” which is grammatically awkward. It would be remedial to add “wherein the nitro fatty acid is administered at”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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 17 and 19 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.
Claim 17 recite the limitation "nitro fatty acid" in first line. There is insufficient antecedent basis for this limitation in the claim. Instant claim 1, from which claims 17 depends, has been amended to recite specific Nrf2 inducers and no longer contains a limitation directed to nitro fatty acid.
Claim 19 contains the limitation “wherein nitro fatty acid is…” It is unclear if nitro fatty acid is supposed to be referring back ‘the nitro fatty acid’ in instant claim 17, which lacks antecedent basis, or if there is an additional component to the composition of nitro fatty acid, as ‘the’ is not used to properly refer back to the previous recitation, thus instant claim 19 has unclear metes and bounds.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
Claim(s) 1, 3, 5-7, 9-10, 17, 19, 22-23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (Applicant provided IDS dated 01/20/2022) in view of US 2014/0024713 (previously applied) as evidenced by PubChem (PubChem, 10-Nitrooleic acid, accessed 12/9/2024, pgs. 1-26).
Regarding claim 1 and 5-7, the limitation of a method for treating nephrogenic diabetes insipidus (NDI) in a subject comprising administering to the subject an active agent thereby treating or preventing the NDI in the subject is met by Kim teaching treating lithium induced nephrogenic diabetes insipidus with a COX-2 inhibitor improves polyuria via upregulation of AQP2 and NKCC2 (title). NSAIDS enhances urinary concentration and these agents have antidiuretic effects in patients with nephrogenic diabetes insipid of different etiologies. Kidney of lithium induced NDI rats with and without Cox-2 inhibition is taught by orally administering. Treatment with COX-2 inhibit so significantly relieved polyuria a raised urine osmolality (abstract).
The limitation of further comprising selecting the subject with the NDI is met by Kim teaching treating lithium induced nephrogenic diabetes insipidus (title) thus teaching selecting a subject with NDI induced by lithium to treat.
Regarding claim 9-10, the limitation of further comprising administering a diuretic and/or a non-steroidal anti-inflammatory agent to the subject, wherein the method decreases polyuria or prevents the development of polyuria is met by Kim teaching treating lithium induced nephrogenic diabetes insipidus with a COX-2 inhibitor improves polyuria via upregulation of AQP2 and NKCC2 (title). NSAIDS enhances urinary concentration and these agents have antidiuretic effects in patients with nephrogenic diabetes insipid of different etiologies.
Kim does not specifically teach a Nuclear factor-erythroid 2 related factor 2 (Nrf2) inducer (claim 1).
Kim does not specifically teach wherein the Nrf2 inducer is selected from a group including the specifically elected 10-nitro-octadec-9-enoic acid (claim 1, 22-23).
The ‘713 publication teaches a 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. The ‘713 publication teaches Examples of topoisomerase inhibitors is taught to include lithium which encompass a toxic medical therapy ([0035]-[0037]). Finally treating does not necessarily occur by administration of one dose but often occurs upon administration of a series of doses [0028]. A variety of side effects may be treated including organ systems including kidneys [0033]. Organ damage may be readily identified using well known pathological techniques [0034]. The lipids may be administered to the subject alone or in combination with one or more other therapeutic agents [0044]. Oral administration is taught and the subject may include mammal such as human or rodent such as rate of mouse [0046], reading on claim 3. The dose may be a single dose [0028] wherein the dose may be 1um to 1g per day [0043], reading on claims 17,19 and 25.
It would have been prima facie obvious before the effective filing date of the claimed invention to use 10-nitrooctadec-9-enoic acid for treatment of NDI as the ‘713 publication teaches the use of 10-nitrooctadec-9-enoic acid to treat lithium induced side effects and Kim teaches NDI to be a lithium induced side effect. It would have been prima facie obvious to one of ordinary skill in the art to use the combination of NSAIDS and 10-nitrooctadec-9-enoic acid to treat NDI as Kim teaches the use of NSAIDS to treat lithium induced NDI wherein NDI is a kidney syndrome and the ‘713 publication teaches 10-nitrooctadec-9-enoic acid is used to treat organ damage to kidneys from toxic treatments such lithium treatment. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success as the ‘713 publication teaches the treatment subject may include rodent and human and may include a combination of active ingredients, this teaching it is known to treat different mammals such as human and include multiple active agents.
Claim(s) 8 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim and US 2014/0024713 as evidenced by PubChem as applied to claims 1, 3, 5-7, 9-10, 17, 19, 22-23 and 25 above, and further in view of US 2014/0377380 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1, 3, 5-7, 9-10, 17, 19, 22-23 and 25 are taught by the combination of Kim and the ‘713.
Regarding claim 24, the limitation of wherein the Nrf2 inducer is 10-nitro-octade-9-enoic acid is met by the ‘713 publication teaching the fatty acid is taught to be 10-nitrooleic acid [0006].
The combination of references does not teach the subject has bipolar disorder (claim 8).
The ‘380 publication teaches treatment of diabetes insipidus disorders (abstract). Acquired nephrogenic diabetes insipidus is common debilitating and morbid condition with a variety of causes [0003]. Treating nephrogenic diabetes insipidus comprising the step of administering an effective amount of a compound to a mammal that is administered a lithium alt, thereby treating nephrogenic diabetes [0012]. The composition is taught to include a lithium salt in combination with a second agent [0013]. Lithium is taught as a maintenance treatment of bipolar disorder and acute treatment of manic episodes of bipolar disorder [0179]. Lithium is taught to have a number of negative effects on the human system including kidney dysfunction [0174]. Acquired nephrogenic diabetes insipidus is lithium induced [0189].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the subject to have bipolar disorder as the ‘380 publication teaches lithium to treat bipolar disorders which may induce NDI and Kim teaches the treatment of lithium induced NDI and the ‘713 publication teaches treating lithium induced side effects. Thus it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a combination of NSAIDS and 10-nitro-octade-9-enoic acid to treat side effects related to lithium treatment such as NDI to patient with bipolar disorder as lithium is known to be used to treat bipolar disorders with side effects such as NDI as taught by the ‘380 publication and Kim and the ‘713 publication teach known methods to treat side effects of lithium treatment.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues there would have been no reasonable expectation based on the ‘713 publication that 10-nitro-octadec-9-enoic acid would could be used for successfully treating NDI. Applicants point out that a prima facie case of obviousness cannot be established by using Applicant’s claims as a guideline for picking and choosing certain features from the prior art when the prior art does not provide any guidance for picking and choosing. The ‘713 publication lists at least 50 possible toxic medical therapies, wherein experimental data in the ‘713 publication focuses on cisplatin which is used for cancer treatment. The ‘713 publication simply includes lithium in an extensive list of possible medical therapies without any additional emphasis or discussion of lithium. The generic mention of kidney damage as in the ‘712 publication does not lead to a conclusion that the treatment disclosed in the ‘713 would be useful for NDI specifically.
In response, Kim teaches treating lithium induced nephrogenic diabetes insipidus with a COX-2 inhibitor improves polyuria via upregulation of AQP2 and NKCC2 (title). The ‘713 publication teaches a 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]. A variety of side effects may be treated including organ systems including kidneys [0033]. Thus Kim teaches a side effect of lithium treatment is NDI and the ‘713 publication teaches that is known to treat side effects of toxic medical therapy using nitrated lipids, wherein kidney is an organ system that is damaged and lithium is taught as a possible medicine used. It would have been prima facie obvious to one of ordinary skill in the art to use the combination of NSAIDS and 10-nitrooctadec-9-enoic acid to treat NDI as Kim teaches the use of NSAIDS to treat lithium induced NDI wherein NDI is a kidney syndrome and the ‘713 publication teaches 10-nitrooctadec-9-enoic acid is used to treat organ damage to kidneys from toxic treatments such lithium treatment. Thus, Kim teaches specifically damage caused by lithium treatment and the ‘713 publication teaches the use of nitro lipids for treating the side effects of toxic medical therapy which includes lithium, thus providing a motivation and expectation of success in using nitro lipids to treat NDI disclosed by Kim.
Applicant argues treatment of NDI with Nrf2 activators confers several advantages compared to other treatment that are not recognized or relied upon prior art. Applicant argues Nrf2 activation did not induce diuresis or otherwise affect volume homeostasis. Applicant pointed to the specification page 39, lines 2-14.
In response, Attorney’s arguments cannot take the place of factual evidence wherein factual evidence is required. Further the instant claim requires the Nrf2 inducer to be present in the composition and treatment of NDI, however it does not require the Nrf2 inducer does the treating of the NDI. Thus Applicant’s arguments are not commensurate in scope with the instant claims. Kim teaches treating lithium induced nephrogenic diabetes insipidus with a COX-2 inhibitor improves polyuria via upregulation of AQP2 and NKCC2 (title).
Conclusion
No claims are allowed.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613