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
Pursuant to the amendment dated 02/02/2026, claims 1, 5, 10-13, 21-25, 27-29, 41-51, 54 and 61-63 were amended, and claims 3 and 7-8 were cancelled. Claims 1-6 and 9-64 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/US2021/026803, filed on 04/12/2021 and claims benefit to 63/119,806 filed on 12/01/2020 and 63/008,099 filed on 04/10/2020.
Withdrawn Rejections
Applicant’s amendment, filed on 01/12/2026, with respect to the rejection of claims 5, 21-24, 29, and 41-51 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, has been fully considered and is persuasive. Applicant has amended claims 5, 21-24, 29, and 41-51 to remove the phrase “first” giving the phrase “administration” proper antecedent basis. The rejection is hereby withdrawn.
Modified Grounds of Rejection
Claim Rejections - 35 USC § 102
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.
(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.
Claims 1, 2, 4-6, 9-14, 16-18, 21, 24-25, and 37-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heerspink et al. (Diabetes Obes Metab, published 03/27/2018, see IDS dated 01/13/2023).
Heerspink is drawn to a method of treating patients with diabetic kidney disease by treating patients with the selective endothelin receptor antagonist atrasentan (abstract). Heerspink teaches that a portion of the patient population were also were taking a SGLT2 inhibitor (page 1831 and Table 2). Heerspink teaches that the albuminuria-lowering effects of atrasentan are similar regardless of concomitant SGLT2 use suggesting that ERAs could complement SGLT2 inhibitors in delaying progressive renal function decline (page 1834).
Regarding claims 4, 5 and 10, Table 2 shows the change from baseline in UACR in patients with and without concomitant SGLT-2 inhibitor use and shows that patients that were administered both atrasentan and an SGLT-2 inhibitor had a greater reduction in UACR than patients only administered atrasentan (page 1834, Table 2).
Regarding claims 16-18, 21 and 24-25, Heerspink teaches that the patients were also being administered a stable and maximum tolerated labelled dose of an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker and a diuretic prior to the enrichment period (page 1830).
Regarding claims 37-40, patients were administered 0.75mg/d of atrasentan for 6 weeks (abstract).
Regarding claims 41-45, patients with type 2 diabetes with an estimated glomerular filtration rate (eGFR) within 25 to 75 mL/min/1.73 m2 and UACR between 300 and 5000 mg/g were enrolled (abstract). Patients had a BNP < 200 pg/mL (page 1830).
Regarding claims 46-51, Table 1 (page 1832) shows the baseline levels of BNP (26-88 pg/mL), serum potassium (4.5 mmol/L), systolic blood pressure (135.9-136.3 mm Hg), HbA1c (7.8 + 1.5), eGFR (41.8 to 43.8 mL/min/1.73 m2), and serum albumin (38.6-39.3 g/L) of the subjects prior to administration of atrasentan.
Regarding claim 52, the instant specification (page 15, paragraph 0055) defines a potassium level within the normal physiologic range when the subject has a blood potassium level of from about 3.5 mmol/L to about 5.2 mmol /L. Heerspink shows that after 6 weeks of treatment, serum potassium levels changed on average 0.05 mmol/L from the baseline, which meets the limitation of instant claim 52 (page 1833, Figure 1).
Regarding claim 58, Heerspink reports that 57.6% of patients also taking calcium channel blockers and 78.4% were taking statins (Table 1).
Regarding instant claim 1 it is noted that Heerspink does not expressly teach that administration of atrasentan and an SGLT-2 inhibitor would result in a reduced BNP level of the subject. However, since the teachings of the prior art teach the administration of the same actives, atrasentan (0.75 mg/d) and an SGLT-2 inhibitor, with the same amount of atrasentan as described in the instant specification (instant specification page 99, example 1 SONAR study, 0.75 mg/d atrasentan) to the same population having diabetic kidney disease, the results would necessarily flow, thereby meeting the instant claim limitations. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Regarding instant claims 1, 6, 9, 11-13, 53-57 it is noted that Heerspink does not expressly teach that administration of atrasentan and an SGLT-2 inhibitor would result in instantly claimed results. However, since the teachings of the prior art teach the administration of the same actives, atrasentan (0.75 mg/d) and an SGLT-2 inhibitor, with the same amount of atrasentan as described in the instant specification (instant specification page 99, example 1 SONAR study, 0.75 mg/d atrasentan) to the same population having diabetic kidney disease, the results would necessarily flow, thereby meeting the instant claim limitations. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Accordingly, the instant claims are anticipated by the teachings of the prior art.
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, 16, 19-20, 24, 26-28, 30-32 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Strumph et al. (CN 102639125 A, published 25/26/2010, see PTO-892 dated 11/03/2025), Miranda-Diaz et al. (J. of Diab. Res., published 05/09/2016, see PTO-892 dated 11/03/2025) and Heerspink et al. (Diabetes Obes Metab, published 03/27/2018, see IDS dated 01/13/2023).
Strumph is drawn to a method for treating a patient suffering from type-2 diabetes by administering to a patient a pharmaceutical composition for the method of the invention, containing dapagliflozin or dapagliflozin -S-propylene glycol solvate and one or more anti-diabetic agents and/or other therapeutic agents (abstract). Strumph teaches that an SGLT2 inhibitor can delay the onset of nephropathy and neuropathy in animals, and enhancing glucose secretion of normalizing blood sugar in the urine of diabetic patients, thereby improving insulin sensitivity, and delaying the development of diabetic complications (paragraph 0002). The SGLT2 inhibitor can be used in combination with one or more antihypertensive agents. The one or more antihypertensive agents includes diuretics (e.g., hydrochlorothiazide, furosemide, bumetanide, amiloride, or spironolactone), ACE inhibitors (e.g. captopril, zofenopril, fosinopril, enalapril, cilazapril, delapril, captopril, quinapril, ramipril or lisinopril), ARB (e.g., losartan, irbesartan, valsartan), ET receptor antagonists (e.g., atrasentan raw planar and compounds disclosed in US5,612,359 and US6,043,265) (paragraph 0258). The therapeutic agent may also be atorvastatin (claim 12).
Strumph does not specifically teach the method of treating chronic kidney disease.
Miranda-Diaz is drawn to a study of oxidative stress in diabetic nephropathy with early chronic kidney disease (title). Miranda-Diaz teaches that diabetic nephropathy (DN) causes ∼44% of all cases of chronic end-stage renal disease (ESRD) in the United States and that DN can progress relatively quickly to CKD (page 1).
The teachings of Heerspink are discussed above.
Heerspink further teaches that a percentage of the patients were also taking statins (78.4%) (Table 1, page 1832).
It would have been prima facie obvious to combine the teachings Strumph, Miranda-Diaz and Heerspink before the effective filing date of the claimed invention by applying the composition comprising an SGLT2 inhibitor such as dapagliflozin and atrasentan as taught by Strumph for the treatment of chronic kidney disease (CKD) as taught by Heerspink to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to apply the composition comprising an SGLT2 inhibitor and atrasentan to treat chronic kidney disease as taught by Strumph because Strumph teaches an SGLT2 inhibitor can delay the onset of nephropathy and neuropathy in animals and delay the development of diabetic complications and may be combined with atrasentan, Miranda-Diaz teaches that DN can progress quickly to CKD, and Heerspink teaches that the combination of atrasentan and an SGLT2 inhibitor may be used for treating CKD. One of ordinary skill in the art would have a reasonable expectation of success because Heerspink teaches that atrasentan and an SGLT2 inhibitor may be used for treating CKD.
Regarding claims 16, 19, 20, 24 and 26-28, it would have been prima facie obvious to combine the teachings Strumph, Miranda-Diaz, and Heerspink before the effective filing date of the claimed invention by modifying the composition taught by Strump containing dapagliflozin and atrasentan to also contain an ACE inhibitor, an ARB, and a diuretic as taught by Strump for the treatment of chronic kidney disease (CKD) as taught by Heerspink to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the composition taught by Strump to also contain an ACE inhibitor, an ARB, and a diuretic because Strump teaches that the composition comprising the SGLT2 inhibitor may also include one or more theraptuetic agents including atrasentan, an ACE inhibitor, an ARB, and a diuretic. One of ordinary skill in the art would have a reasonable expectation of success because Strump teaches the combination of the SGLT2 inhibitor, atrasentan, an ACE inhibitor, an ARB and a diuretic that can delay the onset of neuropathy, Miranda-Diaz teaches that DN can progress quickly to CKD, and Heerspink teaches that a combination of atrasentan and an SGLT2 inhibitor may be used for treating CKD and may be combined with a diuretic and an ACE inhibitor or an ARB. It is noted that Heerspink does not expressly teach that administration of atrasentan and an SGLT-2 inhibitor would result in instantly claimed result of lowering BNP. However, since the teachings of the prior art teach the administration of the same actives, atrasentan (0.75 mg/d) and an SGLT-2 inhibitor, with the same amount of atrasentan as described in the instant specification (instant specification page 99, example 1 SONAR study, 0.75 mg/d atrasentan) to the same population having diabetic kidney disease, the results would necessarily flow, thereby meeting the instant claim limitation. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
Regarding claims 58 and 59, it would have been prima facie obvious to combine the teachings Strumph, Miranda-Diaz, and Heerspink before the effective filing date of the claimed invention modifying by the composition taught by Strump containing dapagliflozin and atrasentan to also contain a statin such as atrovastatin as taught by Strump for the treatment of chronic kidney disease (CKD) as taught by Heerspink to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the composition taught by Strump to also contain a statin such as atrovastatin because Strump teaches that the composition comprising the SGLT2 inhibitor may also include one or more theraptuetic agents including a statin such as atrovastatin. One of ordinary skill in the art would have a reasonable expectation of success because Strump teaches the combination of the SGLT2 inhibitor, atrasentan, and a statin such as atorvastatin and Heerspink teaches that a combination of atrasentan and an SGLT2 inhibitor may be used for treating CKD and may be combined with a statin.
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Heerspink et al. (Diabetes Obes Metab, published 03/27/2018, see IDS dated 01/13/2023) and Wolkart et al. (British Journal of Pharmacology, published 01/29/2009, see PTO-892 dated 11/03/2025).
The teachings of Heerspink are discussed above.
Heerspink does not teach the application of atrasentan and an SGLT2 inhibitor for treatment of CKD of patients with type 1 diabetes (T1D).
Wolkart is drawn to the study of the cardioprotective effects of atrasentan in diabetic mice and showed that atrasentan reduced diabetic urine flow, proteinuria and plasma creatinine levels. The results suggest that in experimental T1D, blocking ETA receptors ameliorates myocardial, coronary and renal function and improves tissue oxidant status (abstract). Wolkart showed that oral application of the endothelin ETA receptor antagonist atrasentan for 4 weeks ameliorated myocardial function, microvascular coronary function, tissue oxidant status and some aspects of renal function (page 676). Wolkart teaches that the establishment of hyperglycaemia as a key initiating factor for the development of chronic diabetic complications has been a milestone in diabetes research. Vascular endothelial cells, cardiac myocytes and the kidneys are important targets of hyperglycaemic damage in patients with type 1 and type 2 diabetes. Hyperglycaemia is known to impair endothelium-dependent regulation of vascular tone, to promote the development of diabetic cardiomyopathy with impaired systolic and diastolic function, and to exacerbate end-stage renal disease. Further, high glucose induces ET-1 expression in endothelial cells and the diabetic state is associated with altered ET-1 action and impaired Ca2+ -dependent endothelial responses (page 671).
It would have been prima facie obvious to combine the teachings of Heerspink and Wolkart before the effective filing date of the claimed invention by using the method of treating CKD with a composition comprising atrasentan and an SGLT2 inhibitor as taught by Heerspink to treat T1D patients as taught by Wolkart to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to treat T1D patients that have CKD with the composition of atrasentan and an SGLT2 inhibitor as taught by Heerspink because Wokart teaches that atrasentan may be used in T1D subjects to improve renal function. One of ordinary skill in the art would have a reasonable expectation of success because Wolkart teaches that in T1D subjects, atrasentan can be used to improve renal function and reduce plasma creatine levels.
Claims 1, 21-23 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Heerspink et al. (Diabetes Obes Metab, published 03/27/2018, see IDS dated 01/13/2023) and ClincalTrials.gov (NCT01858532, https://clinicaltrials.gov/study/NCT01858532?tab=history&a=22#version-content-panel, accessed 10/22/2025, published 03/29/2019, see PTO-892 dated 11/03/2025).
The teachings of Heerspink are discussed above.
Heerspink further teaches that during the recruitment for the SONAR trial SGLT2 inhibitors were already being used by a few patients (page 1834).
Heerspink does not teach wherein the subject has been administered a maximally tolerated stable does of an ACE inhibitor or an ARB for at least 4 weeks, 10 weeks, or 12 weeks prior to the first administration of atrasentan. Heerspink does not teach wherein the subject has been administered a SGLT-2 inhibitor for at least 12 weeks prior to the first administration of atrasentan.
NCT01858532 teaches that the patients were administered the ACE inhibitor or ARB for greater than 4 weeks and up to 12 weeks prior to administration of atrasentan. Prior to the treatment period, there was a run-in period up to 12 weeks and an enrichment period of 6 weeks.
Regarding claims 21-23, it would have been prima facie obvious to combine the teachings of Heerspink and NCT1858532 before the effective filing date of the claimed invention by administering the ACE inhibitor or ARB for greater than 4 weeks and up to 12 weeks as taught by NCT1858532 prior to administration of atrasentan as taught by Heerspink to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to administer the ACE inhibitor or ARB for greater than 4 weeks and up to 12 weeks prior to administration of atrasentan because NCT1858532 teaches the administration of the ACE inhibitor or ARB prior to the atrasentan administration. One of ordinary skill in the art would have a reasonable expectation of success because NCT1858532 teaches the administration of the ACE inhibitor or ARB prior to the atrasentan administration
Regarding claim 29, it would have been prima facie obvious to combine the teachings of Heerspink and NCT1858532 before the effective filing date of the claimed invention by administering the SGLT2 inhibitors to the patients 12 weeks before the administration as taught of the atrasentan as taught by SGLT2 to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to administer the SGLT2 inhibitors to the patients 12 weeks before the administration because Heerspink teaches that the patients were already taking the SGLT2 inhibitors during the recruitment for the trial, and NCT1858532 teaches that the time between recruitment and administration of the atrasentan was at least 12 weeks.
Claims 1 and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Heerspink et al. (Diabetes Obes Metab, published 03/27/2018, see IDS dated 01/13/2023) and Huang (US 20150011602 A1, published 01/08/2015, see PTO-892 dated 11/03/2025).
The teachings of Heerspink are discussed above.
Heerspink is silent on the form of atrasentan.
Huang is drawn to stabilized pharmaceutical dosage forms comprising atrasentan, or a pharmaceutically acceptable salt thereof, and, optionally, another therapeutic agent and methods of using such pharmaceutical dosage forms to treat nephropathy, chronic kidney disease, and/or other conditions (abstract). Huang teaches the dosage form can comprise a free base of atrasentan or a hydrochloride salt of atrasentan (paragraph 0075).
It would have been prima facie obvious to combine the teachings of Heerspink and Huang before the effective filing date of the claimed invention by selecting the atrasentan to be either the free base form or the hydrochloride form of atrasentan as taught by Huang for the treatment of CKD with an SGLT2 inhibitor as taught by Heerspink to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to select either the free base form or the hydrochloride salt form of atrasentan because Huang teaches a stable pharmaceutical dosage of atrasentan in the free base form or as the hydrochloride salt for the treatment of CKD. One of ordinary skill in the art would have a reasonable expectation of success because Huang teaches a stable pharmaceutical dosage of atrasentan in the free base form or as the hydrochloride salt for the treatment of CKD and Heerspink teaches the method of treating CKD with atrasentan and an SGLT2 inhibitor.
Claims 1 and 60-64 are rejected under 35 U.S.C. 103 as being unpatentable over Heerspink et al. (Diabetes Obes Metab, published 03/27/2018, see IDS dated 01/13/2023), ClincalTrials.gov (NCT01858532, https://clinicaltrials.gov/study/NCT01858532?tab=history&a=22#version-content-panel, accessed 10/22/2025, published 03/29/2019, see PTO-892 dated 11/03/2025), and Pullamsetti et al. (Sci. Transl. Med., published 11/15/2017, see PTO-892 dated 11/03/2025).
The teachings of Heerspink are discussed above.
Heerspink does not specifically teach that the subject has not been previous diagnosed with or currently treated for one or more of IgA nephropathy, HIV/AIDS, HIV-related nephropathy or acute kidney failure. Heerspink does not specifically teach that the subject has not been previous diagnosed with or currently treated with cancer wherein the cancer is lung cancer or prostate cancer.
Heerspink does not specifically teach that patients would not be eligible for the method of treating CKD with atrasentan and an SGLT2 inhibitor if the patient is being treated for lung cancer.
The teachings of NCT01858532 were discussed above. NCT01858532 further teaches that patients were ineligible if the subject had a history of pulmonary hypertension, pulmonary fibrosis or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema).
Pullamsetti is drawn to the study of lung cancer-associated pulmonary hypertension (title). Pullamsetti teaches that nearly half of lung cancer patients have pulmonary hypertension (abstract).
It would have been prima facie obvious to combine the teachings of Heerspink, NCT01858532, and Pullamsetti before the effective filing date of the claimed invention by excluding patients as taught by NCT01858532 from the method taught by Heerspink that have lung cancer-associated pulmonary hypertension as taught by Pullamsetti to arrive at the claimed invention. It would have been prima facie obvious for a person of ordinary skill in the art to exclude lung cancer patients because NCT01858532 teaches the exclusion of patients with pulmonary hypertension and Pullamsetti teaches that nearly half of lung cancer patients have pulmonary hypertension.
Response to Arguments
Applicant's arguments filed 02/02/2026 have been fully considered, but they are not persuasive.
Applicant argues that Heerspink fails to teach that the administration of therapeutically effective amounts of atrasentan, or a salt thereof, and an SGLT2 inhibitor to reduce a subject's BNP level. Applicant further argues that Heerspink reports increased BNP levels during the enrichment period (Fig. 1, page 1833). The argument is not persuasive. The reported figures in Figure 1 were the result of a population comprising both subjects that were administered the combination of atrasentan and an SGLT2 inhibitor and subjects that were administered atrasentan without an SGLT2 inhibitor without distinguishing between the two. The change in BNP reported by Heerspink in Figure 1 is not the same population of the instantly claimed of only subjects administered atrasentan and an SGLT2 inhibitor. Thus, the teachings of the prior art teach the administration of the same actives, atrasentan (0.75 mg/d) and an SGLT-2 inhibitor, with the same amount of atrasentan as described in the instant specification (instant specification page 99, example 1 SONAR study, 0.75 mg/d atrasentan) to the same population having diabetic kidney disease, the results would necessarily flow, thereby meeting the instant claim limitations. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
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.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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