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 1-12 are presented for examination.
Applicants’ drawings and preliminary amendment filed April 5, 2023 have been received and entered.
Applicants’ information disclosure statements filed August 7, 2023 and September 24, 2025 have been received and entered.
Applicants’ election filed September 24, 2025 in response to the restriction requirement of July 24, 2025 has been received and entered. The applicants elected the invention described in claims 1-9 (Group I) with traverse. Applicants’ traverse is noted, but is not deemed persuasive for reasons set forth in the previous Office action dated July 24, 2025; therefore, the restriction requirement is hereby made Final.
Claims 10-12 are withdrawn from consideration as being drawn to the non-elected invention (37 CFR 1.142(b)).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sands et al., “Physiological insights into novel therapies for nephrogenic diabetes insipidus”, American Journal of Physiology Renal Physiology, Vol. 311, No. 1, pages F1149-F1152 (2016) of PTO-1449.
Sands et al. teaches a combination of a vasopressin receptor antagonist, such as tolvaptan, and an activator of adenosine monophosphate active protein kinase, such as metformin, for use in treatment of kidney function decline preventing polyuria (see page F1151, column 2, first paragraph, lines 16-19). Also note on page F1151, column 2, first paragraph, lines 14-16 teaches the tolvaptan is approved for the treatment of autosomal dominant polycystic kidney disease (ADPKD) that can result in iatrogenic NDI that causes polyuria, thus inherently treating polyuria with the addition of metformin.
Clearly, the cited reference anticipates applicants’ instant invention of treating or preventing polyuria as a side effect of a vasopressin receptor antagonist therapy, such as tolvaptan, in combination with an activator of AMPK, such as metformin; therefore, applicants’ instant invention is unpatentable.
Claims 1-4 are not allowed.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 5-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2018/144570 A1, hereby known as Sands et al. of PTO-1449.
Sands et a. teach methods for treating or preventing nephrogenic diabetes insipidus and its associated complications with the administration of compound of formula I or derivative thereof. Note page 2, lines 1-15 teaches the compound of formula I is NDI-5033 (NP-5033). Note page 2, lines 16-17 teaches treatments of excessive urination (polyuria). Note page 20, lines 1-2 teaches the therapeutically effective amount of NDI-5033 may be from about 0.1 mg/day to about 3,000 mg/day. Note page 20, line 17 teaches the preferred range from about 10 mg/day to about 3,000 mg/day. Note page 22, line 7 teaches the NDI-5033 can be administered orally. Also note page 25, EXAMPLES, teaches a combination of tolvaptan (a vasopressin receptor antagonist) and NDI-5033 (an activator of AMPK). Wherein tolvaptan caused reduce urine osmolality and then the administration of NDI-5033 improved urine concentrating ability to 75% normal.
Clearly, the cited reference anticipates applicants’ instant invention of treating or preventing polyuria as a side effect of a vasopressin receptor antagonist therapy, such as tolvaptan, in combination with an activator of AMPK, such as NDI-5033 (NP-5033); therefore, applicants’ instant invention is unpatentable.
Claims 5-7 are not allowed.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2018/144570 A1, hereby known as Sands et al. of PTO-1449, taken in evidence with Sands et al., “Physiological insights into novel therapies for nephrogenic diabetes insipidus”, American Journal of Physiology Renal Physiology, Vol. 311, No. 1, pages F1149-F1152 (2016) of PTO-1449.
Sands et al. were discussed above supra for the treatment or prevention of excessive urination (polyuria) caused by the administration of tolvaptan, a side effect, with the administration of an activator of AMPK, NDI-5033 (NP-5003). Note the evidence reference, Sands et al., teaches on page F1151, column 2, first paragraph, lines 14-16 that tolvaptan is well-known to treat autosomal dominant polycystic kidney disease (ADPKD). Therefore, the administration of the combination of tolvaptan and NDI-5033 (NP-5033) will, inherently treat ADPKD.
Claims 8-9 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629