Prosecution Insights
Last updated: July 17, 2026
Application No. 17/996,816

COMBINATION OF FINERENONE AND A SGLT2 INHIBITOR FOR THE TREATMENT AND/OR PREVENTION OF CARDIOVASCULAR AND/OR RENAL DISEASES

Final Rejection §103§112§DOUBLEPATENT§DP
Filed
Oct 21, 2022
Priority
Apr 22, 2020 — EU 20170936.7 +5 more
Examiner
CRAIGO, BAHAR ALAWI
Art Unit
1699
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Bayer Aktiengesellschaft
OA Round
2 (Final)
47%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
74%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allowance Rate
366 granted / 782 resolved
-13.2% vs TC avg
Strong +27% interview lift
Without
With
+27.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
49 currently pending
Career history
840
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
57.1%
+17.1% vs TC avg
§102
5.5%
-34.5% vs TC avg
§112
4.1%
-35.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 782 resolved cases

Office Action

§103 §112 §DOUBLEPATENT §DP
DETAILED ACTION This Office Action is in response to Applicant’s Amendment and Remarks filed on 05 March 2026 in which claims 5, 6, 13 and 14 were canceled, claims 15 and 20 were amended to change the scope and breadth of the claims, and claims 22-25 were newly added. Claims 1-4, 7-11 and 15-25 are pending in the current application. Claims 1-4 and 7-11 remain withdrawn as being drawn to a non-elected invention. Claims 15-25 are examined on the merits herein. 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 Withdrawn Objection & Rejections Applicant’s amendment, filed 05 March 2026, with respect to the objection of claims 5, 13 and 14, has been fully considered and is persuasive, because the claims have been canceled. The objection is hereby withdrawn. Applicant’s amendment, filed 05 March 2026, with respect to the objection of claims 5, 6 and 13-21, has been fully considered and is persuasive, because 5, 6, 13 and 14 have been canceled, and claims 15-21 are no longer dependent on a withdrawn claim. The objection is hereby withdrawn. Applicant’s amendment, filed 05 March 2026, with respect to the rejection of claims 5, 6 and 13-21 under 35 U.S.C. § 112, first paragraph, for scope of enablement, has been fully considered and is persuasive because claims 5, 6, 13 and 14 have been canceled, and claim 15 has been amended to delete “preventing”. The claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification. The rejection is hereby withdrawn. Applicant’s amendment, filed 05 March 2026, with respect to the rejection of claim 13 under 35 U.S.C. § 112(b), second paragraph, for indefiniteness, has been fully considered and is persuasive because the claim has been canceled. The rejection is hereby withdrawn. Applicant’s amendment, filed 05 March 2026, with respect to the rejection of claims 5, 6, 13-19 and 21 under 35 U.S.C. § 102(a)(2), as being anticipated by Langkilde, has been fully considered and is persuasive because the claim has been amended to recite “wherein the combination therapy is a single dosage form”. The claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification. The rejection is hereby withdrawn. Response to Arguments Applicant's arguments filed 05 March 2026 have been fully considered but they are not persuasive. Applicant has pointed to the Specification, which shows the combination of finerenone with an SLGT2 inhibitor leads to over-additive sodium excretion compared to monotherapy with either Finerenone or an SGLT2 inhibitor alone (Tables 4-5, and Figs 4-5). The data has been reviewed. Applicant has shown the combination of finerenone with an SLGT2 inhibitor leads to over-additive sodium excretion compared to monotherapy with either finerenone or an SGLT2 inhibitor alone. However, it does not overcome the prima facie case of obviousness, because it is not clear if these results are unexpected, because they are not compared to the closest prior art. The closest prior art is Langkilde, which discloses administering SGLT2 to patients actively taking MR agents. As noted in the previous Office Action, MR agents are chosen from finerenone, esaxerenone, KBP-5074, and apararenone. In order to show unexpected results, Applicant must provide a side-by-side comparison where the SGLT2 inhibitor and finerenone are administered separately versus as a single dosage form. See MPEP 716.02(e), “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.”. The rejection is hereby maintained. New & Modified Rejections The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 05 March 2026, where the limitations in pending claims 15, 19 and 20 as amended now have been changed and claims 22-25 have been newly added. Therefore, rejections from the previous Office Action, dated 11 December 2025, have been modified and are listed below. 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 20-24 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. The recitation “wherein the combination therapy is selected from the group consisting of or is part of a fixed combination and a combination pack” in claim 20 renders the claim herein indefinite. According to paragraph [0055] of the published application, the active substances in a “combination pack” are included in separate dosage forms marketed in the same package. A combination is different from a combined pharmaceutical dose form. Thus, a combination pack does not have antecedent basis from claim 15. Furthermore, the term “fixed combination” appears to refer to refer to a type of pharmaceutical dosage form. However, claim 20 suggests it is part of the mode of treatment/therapy. Thus, the use of the term “wherein the combination therapy…is part of a fixed combination” renders the claim herein indefinite. It’s unclear if Applicant meant the single dosage form is formulated as a fixed combination. Clarification is respectfully requested. The recitation “wherein the disease is chronic kidney disease” in claim 22 renders the claim herein indefinite. Claim 21 depends from claim 15, which is directed towards “treating a cardiovascular and/or renal disease”. Since claim 15 is directed towards one or two diseases, it is unclear which disease claim 21 is referring to and further limiting. Claims 23 and 24 are similarly indefinite. Claims 22-24 recite a list of diseases. However, not all of these are a cardiovascular and/or renal disease. Thus, diseases like cirrhosis, and NASH, and others lack antecedent basis. Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 20 and 22-24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The recitation “wherein the combination therapy is selected from the group consisting of or is part of a fixed combination and a combination pack” in claim 20 fails to further limit the subject matter upon which it depends. Claim 20 depends from claim 15, which recites “wherein the combination therapy is a single dosage form”. According to paragraph [0055] of the published application, the active substances in a “combination pack” are included in separate dosage forms marketed in the same package. A combination is different from a combined pharmaceutical dose form. Thus, a combination pack does not include “a single dosage form”, which is required in claim 15. The recitation “wherein the disease is selected from the group consisting of cardiovascular disorders” in claim 22, renders the claim herein indefinite. Claim 22 depends from claim 15, which already recites “cardiovascular disease”. Thus, this alternative fails to further limit claim 15. Claims 22-24 also recite a list of diseases. However, not all of these are a cardiovascular and/or renal disease. Thus, diseases like cirrhosis, and NASH, and others fail to further limit the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 103 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 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. 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) 15-24 are rejected under 35 U.S.C. 103 as being unpatentable over Langkilde (US Patent No. 10,973,836, cited in previous Office Action). Langkilde teaches methods of treating patients with heart failure with reduced ejection fraction (HFrEF), with and without type 2 diabetes, with an SGLT2 inhibitor, such as dapagliflozin (abstract). Langkilde teaches the separate, sequential or simultaneous administration of a mineralocorticoid receptor (MR) agents and SGLT2 (MRA; MR agents and MRA used interchangeably; col.11:43-57). Langkilde discloses “many of our patients had chronic kidney disease”, and did not suffer from worsening renal function or volume depletion (col. 40: 34-54). “Serious renal adverse events were uncommon generally, and significantly less frequent in the dapagliflozin group” (col. 40: 46-48). The patients tested in examples 2 and 3 taking dapagliflozin included those with low eGFR, and taking MR agents (Tables 3, and 5). According to Table 1, 40.7% of the patients taking dapagliflozin had an estimated eGFR of <60 ml/min/1.73 m2. The eGFR rate on average was 66.0 mL/min/1.73 m2 (see col. 33-36). In some embodiments, the SGLT2 inhibitor is dapagliflozin, and the MRA is chosen from finerenone, esaxerenone, KBP-5074, and apararenone (col.11: 58-65). Langkilde discloses administering 10 mg dapagliflozin, including for patients taking MRA and having an eGFR <60 (fig. 4; also see col.3:43-48). Langkilde discloses orally administering an SGLT2 inhibitor at 2.5 mg, 5.0 mg, or 10.0 mg, once a day (also see col. 32:29-55). Langkilde discloses dapagliflozin can be formulated as a fixed-dose combination product with another therapeutic agent, e.g. dapagliflozin/metformin extended release (col. 23:61-67). Additional alternative SGLT2 inhibitors include empagliflozin (e.g. col.2:58-62; col.20:57-67; col.23:19-25; col.25:36-50; col.30:53-57). Langkilde does not expressly disclose administering the combination of finerenone and SGLT2 inhibitor (empagliflozin or dapagliflozin) as a single dosage form (present claim 15). Furthermore, while Langkilde exemplify administering dapagliflozin in combination with MR agents including finerenone, Langkilde does not expressly disclose administering empagliflozin to treat CKD or HFrEF (elected species of SGLT2 inhibitor). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer empagliflozin in combination with finerenone to treat CKD or HFrEF; and to administer either dapagliflozin or empagliflozin with finerenone in a single dosage form. According to Langkilde, treating HFrEF is the primary purpose of administering the SGLT2 inhibitor. Langkilde acknowledges the majority of the patients in the study had chronic kidney disease. Concomitant administration of dapagliflozin with MRA was acceptable and did not worsen renal outcomes. More specifically, Langkilde found patients did not experience adverse events related to renal dysfunction while under treatment with the SGLT2 inhibitor. Thus, it would have been obvious to administer dapagliflozin and an MR agent to a patient having CKD and HFrEF with a reasonable expectation of success. One having ordinary skill in the art would have been motivated to substitute dapagliflozin with empagliflozin because Langkilde discloses empagliflozin and dapagliflozin as suitable alternative SGLT2 inhibitors. The ordinary artisan would have been motivated to administer either dapagliflozin or empagliflozin in combination with finerenone to treat CKD or HFrEF, because Langkilde teaches four suitable MR agents, including finerenone, esaxerenone, KBP-5074, and apararenone. One having ordinary skill in the art would have been motivated to administer the SGLT2 inhibitor with MRA in a single dosage form, because Langkilde teach simultaneous administration of an MRA and SGLT2, and found patients did not experience adverse events related to renal dysfunction under treatment with the SGLT2 inhibitor and MRA. Additionally, Langkilde discloses dapagliflozin is formulated as a fixed-dose combination product with another therapeutic agent, e.g. dapagliflozin/metformin extended release (col. 23:61-67). Thus, the ordinary artisan would have been motivated to also administer the SGLT2 inhibitor/MRA as a fixed dose combination product. Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art. Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Langkilde as applied to claims 15-24 above, and further in view of Filippatos et al. (European Heart Journal, 2016, vol. 37, pp. 2105-2114, cited in PTO-892). Langkilde teaches as discussed above. Langkilde does not expressly disclose administering 20 mg finerenone (present claim 25). Filippatos et al. teach finerenone is a novel non-steroidal MRA, with higher selectivity towards the mineralocorticoid receptor (MR) compared with spironolactone and stronger MR-binding affinity than eplerenone (p.2106, second para). Finerenone is expected to have a more pronounced cardiorenal protection, particularly in high-risk patients with impaired kidney disease. Filippatos et al. studied the effect of administering 20 mg finerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease (title, abstract). Filippatos et al. found finerenone was well tolerated and induced a 30% or greater decrease in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP). Prospective studies showed decreases in plasma NT-proBNP concentrations of 30% or more correlate with improved prognosis (p.2113, Study Limitations). Filippatos et al. found clinical events were the lowest in the patient group receiving 10 mg finerenone uptitrated to 20 mg (abstract: conclusion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer 20 mg finerenone to patients with heart failure and chronic kidney disease, because in the same field of endeavor of using finerenone as Langkilde, Filippatos et al found 10 mg finerenone uptitrated to 20 mg finerenone induced a 30% or greater decrease in NT-proNB, with the lowest observed clinical events. Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art. Response to Arguments Applicant has requested that the provisional rejections be held in abeyance until patentable subject matter is identified. The obviousness double patenting rejections are hereby maintained. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 19/169,800 (reference application) in view of Langkilde. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘800 application are directed towards administering finerenone with an SGLT2 inhibitor (see claim 5) to treat patient having an eGFR ≤ 15 ml/min/1.73 m2. The ’800 application does not expressly disclose the SGLT2 inhibitor is dapagliflozin or empagliflozin. Langkilde teaches as discussed above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer empagliflozin in combination with finerenone to treat CKD or HFrEF; and to administer either dapagliflozin or empagliflozin with finerenone in a single dosage form. One having ordinary skill in the art would have been motivated to substitute dapagliflozin with empagliflozin because Langkilde discloses empagliflozin and dapagliflozin as suitable alternative SGLT2 inhibitors. The ordinary artisan would have been motivated to administer either dapagliflozin or empagliflozin in combination with finerenone to treat CKD or HFrEF, because Langkilde teaches four suitable MR agents, including finerenone, esaxerenone, KBP-5074, and apararenone. The primary purpose of the ‘800 application and Langkilde is to treat heart failure with finerenone. The ‘800 application claims the patients have end stage kidney disease. Additionally, Langkilde acknowledges the majority of the patients in the study had chronic kidney disease (an eGFR ≤ 15 ml/min/1.73 m2). Concomitant administration of dapagliflozin with MRA was acceptable and did not worsen renal outcomes. More specifically, Langkilde found patients did not experience adverse events related to renal dysfunction while under treatment with the SGLT2 inhibitor. Thus, it would have been obvious to administer dapagliflozin or empagliflozin with an MR agent to a patient having CKD and HFrEF with a reasonable expectation of success. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 9, 11, 13, 16, 17, 19-21, 23, 24, 26, 30-32, 36, 39-41, 46-50 and 56 of copending Application No. 19/009,124 (reference application) in view of Langkilde. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are directed towards administering finerenone with an SGLT2 inhibitor (see claim 11) to treat patient having an eGFR ≤ 15 ml/min/1.73 m2. The reference application does not expressly disclose the SGLT2 inhibitor is dapagliflozin or empagliflozin. Langkilde teaches as discussed above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer empagliflozin in combination with finerenone to treat CKD or HFrEF; and to administer either dapagliflozin or empagliflozin with finerenone in a single dosage form. One having ordinary skill in the art would have been motivated to substitute dapagliflozin with empagliflozin because Langkilde discloses empagliflozin and dapagliflozin as suitable alternative SGLT2 inhibitors. The ordinary artisan would have been motivated to administer either dapagliflozin or empagliflozin in combination with finerenone to treat CKD or HFrEF, because Langkilde teaches four suitable MR agents, including finerenone, esaxerenone, KBP-5074, and apararenone. The primary purpose of the reference application and Langkilde is to treat heart failure with finerenone. The reference application claims the patients have end stage kidney disease. Additionally, Langkilde acknowledges the majority of the patients in the study had chronic kidney disease (an eGFR ≤ 15 ml/min/1.73 m2). Concomitant administration of dapagliflozin with MRA was acceptable and did not worsen renal outcomes. More specifically, Langkilde found patients did not experience adverse events related to renal dysfunction while under treatment with the SGLT2 inhibitor. Thus, it would have been obvious to administer dapagliflozin or empagliflozin with an MR agent to a patient having CKD and HFrEF with a reasonable expectation of success. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 19/385,125 (reference application) in view of Langkilde. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are directed towards administering finerenone with an SGLT2 inhibitor (see claim 11) to treat patient having an eGFR ≤ 15 ml/min/1.73 m2. The reference application does not expressly disclose the SGLT2 inhibitor is dapagliflozin or empagliflozin. Langkilde teaches as discussed above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer empagliflozin in combination with finerenone to treat CKD or HFrEF; and to administer either dapagliflozin or empagliflozin with finerenone in a single dosage form. One having ordinary skill in the art would have been motivated to substitute dapagliflozin with empagliflozin because Langkilde discloses empagliflozin and dapagliflozin as suitable alternative SGLT2 inhibitors. The ordinary artisan would have been motivated to administer either dapagliflozin or empagliflozin in combination with finerenone to treat CKD or HFrEF, because Langkilde teaches four suitable MR agents, including finerenone, esaxerenone, KBP-5074, and apararenone. The primary purpose of the reference application and Langkilde is to treat heart failure with finerenone. The reference application claims the patients have end stage kidney disease. Additionally, Langkilde acknowledges the majority of the patients in the study had chronic kidney disease. Concomitant administration of dapagliflozin with MRA was acceptable and did not worsen renal outcomes. More specifically, Langkilde found patients did not experience adverse events related to renal dysfunction while under treatment with the SGLT2 inhibitor. Thus, it would have been obvious to administer dapagliflozin or empagliflozin with an MR agent to a patient having CKD and HFrEF with a reasonable expectation of success. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion In view of the rejections to the pending claims set forth above, no claim is 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /BAHAR CRAIGO/ Primary Examiner Art Unit 1699
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Prosecution Timeline

Oct 21, 2022
Application Filed
Dec 11, 2025
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT
Mar 05, 2026
Response Filed
Apr 29, 2026
Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)

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Prosecution Projections

3-4
Expected OA Rounds
47%
Grant Probability
74%
With Interview (+27.0%)
3y 4m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 782 resolved cases by this examiner. Grant probability derived from career allowance rate.

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