DETAILED ACTION
The amendment submitted on April 20, 2025 has been entered. Claims 16-35 are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 . 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.
Withdrawn Rejections
The rejection of claims 23-24 under 35 U.S.C. 112(d) is withdrawn in view of applicant’s corrective amendment.
The rejection of claims 20-22 under 35 U.S.C. 112(b) as being indefinite is likewise with-drawn.
Response to Arguments
Applicant takes mutually contradictory positions, on the one hand arguing that there is a lack of predictability in this technology area, and on the other hand, arguing that it is readily predictable. Applicant’s inconsistent arguments are not persuasive. For example, applicant argues that “[n]one of the cited references demonstrate that FXR modulation can reverse or treat established renal fibrosis or provide therapeutic benefit across the spectrum of renal diseases recited in the claims.” See applicant’s Remarks, submitted April 20, 2026, at p. 8. But neither has applicant. The evidence in applicant’s own specification (pp. 13-17) is limited to in vivo experiments concerning interstitial fibrosis, whereas the instant claims are drawn to a broad list of renal diseases. Applicant states the “[r]enal fibrosis and CKD [chronic kidney disease] are complex, multifactorial conditions involving distinct cellular pathways,” see applicant’s Remarks at p. 9, but applicant nevertheless asserts that the compounds at issue are useful for a broad range of kidney disease even though there is no evidence to support this position. In fact, independent claim 16 appears to be drawn to kidney diseases that have nothing to do with fibro-sis. Applicant also argues that the compounds of claims 17-18 both have a halogen, so they should be expected to have more or less the same properties. Remarks at pp. 10-11. Applicant has no specific evidence to support this conclusion, other than the assumption that similar compounds are expected to have similar properties. That is, applicant argues that it is readily predictable that the compounds of claims 17-18 have more or less the same properties. The best evidence before the examiner is that this is that FXR agonists reduce interstitial fibrosis (see, e.g., the Title of Li et al.). The examiner also maintains that it is readily predictable that the FXR agonist of Roche would be useful in treating interstitial renal fibrosis.
With respect to double patenting, applicant reiterates that expiration dates are the controlling factor for nonstatutory double patenting. See applicant’s Remarks at pp. 11-12. As explained in the prior action, however, another policy objective is to prevent possible harassment by multiple assignees. Current Office policy is set forth in MPEP 804, which requires a terminal disclaimer. Applicant further argues that the “claims of this application do not recite the L-lysine salt recited in the claims of the ‘861 patent,” so the instant claims are not prima facie obvious over this patent. Remarks at pp. 11. The instant claims, however, are drawn to certain compounds “or a pharmaceutically acceptable salt thereof.” The L-lysine salt claimed in the ‘861 Patent is within the meaning of “pharmaceutically acceptable salt” as recited in the instant claims, so the rejection for double patenting is proper.
Applicant’s arguments, including the Rule 132 Declaration, submitted on April 20, 2026 have been fully considered but are not persuasive. The rejections are therefore maintained.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obvious-ness 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) resolv-ing the level of ordinary skill in the pertinent art; and (4) considering objective evidence present in the application indicating obviousness or nonobviousness. See MPEP1 2141 et seq.
Claims 16-19, 23-30, and 34-35 remain rejected under 35 U.S.C. 103 as being unpatent-able over US 2011/0105475 A1 by Roche et al. in view of Levi, Biochim. Biophys. Acta 2011;1812(8):1061-67, Masaoutis et al., Expert Opin. Ther. Targets 2019;23(2):107-16, and Li et al., FASEB J. 2019;33(6):7103-12.
Roche (cited in the prior action) discloses the two compounds recited in claims 17 and 18. See the compounds at para. 0201 and 0203, respectively. These compounds are modulators of farnesoid X receptor (FXR), which is expressed in the kidney (para. 0002-04) and “regulates diverse physiological processes” (para. 0006). The compounds are useful in methods of treating a wide variety of diseases, including nephropathy, i.e., kidney diseases (para. 0001).
The difference between the prior art and the claims at issue is that this reference does not specifically disclose the particular kidney diseases recited in claims 19-30. These diseases, however, were known in the prior art to be associated with FXR dysfunction, as explained in Levi, Masaoutis, and Li.
Levi (cited in the prior action) discloses that FXR has “particularly high expression in the kidney” and FXR activation is associated with chronic kidney disease. See “Farnesoid X receptor” at pp. 1062-63. “FXR agonists can prevent the progression of kidney disease in mouse models of type 1 diabetes mellitus, diet induced obesity and insulin resistance, and type 2 diabetes mellitus” (p. 1063), which suggests subject matter within the scope of claim 23. FXR knockout mice develop tubulointerstitial fibrosis (p. 1063), which suggest subject matter within the scope of claim 24.
Masaoutis (also cited in the prior action) discloses that “FXR serves a significant role in renal physiology and disease” (p. 108). “FXR mediates mainly nephroprotective effects by targeting simultaneously multiple pathogenetic mechanisms culpable of renal disease on both renal and systemic levels” (p. 109). Among these renal diseases are diabetes (p. 112); kidney damage in obesity (p. 109); renal fibrosis (p. 109); podocyte loss (p. 113), i.e., podocytopathy; diabetic nephropathy (p. 109); glomerulonephritis (p. 109); interstitial nephritis (p. 109); and a variety of other chronic kidney diseases within the meaning of the instant claims.
Li (also cited in the prior action) discloses that “FXR is highly expressed within the kidney, and studies have demonstrated that FXR activation can mitigate renal injury” (p. 7111). FXR activation has been “shown to modulate … renal expression of inflammatory cytokines and fibrotic markers,” and “FXR activation suppresse[s] renal fibrosis” (p. 7104). The progression of chronic kidney disease (CKD) includes glomerulosclerosis and interstitial fibrosis (p. 7103).
It would have been prima facie obvious to one of ordinary skill in the art as of the effective filing date to use the compounds of Roche in the treatment of the FXR-mediated diseases taught by Levi, Masaoutis, and Li and thereby arrive at subject matter within the scope of the instant claims. It is the natural motivation of the skilled artisan to use existing drugs in accordance with their known or expected pharmacological properties and thereby arrive at readily predictable outcomes. See MPEP 2144.07 (the selection of a known material based on its suitability for its intended use is generally considered to be prima facie). Apprised of the activity of the two compounds taught by Roche as FXR modulators, it would have been apparent to the skilled artisan that they would be useful in the treatment of FXR-mediated disease. One would have had a reasonable expectation of success because the implicit disclosure of Roche is that these compounds are widely useful in the treatment of a broad range of different diseases, including “nephropathy” (para. 0023), i.e., kidney disease. It is therefore a reasonable expectation that the compounds of Roche would be useful in the diseases described in Levi, Masaoutis, and Li.
The subject matter of claims 29-30 would have been a matter of common sense to the skilled artisan inasmuch as administration one or more times per day is routine in the practice of clinical medicine.
Claims 20-22 remain rejected under 35 U.S.C. 103 as being unpatentable over Roche, Levi, Masaoutis, and Li applied above, and further in view of Levey et al., JAMA 2015;313(8):837-46.
The disclosures of Roche, Levi, Masaoutis, and Li are relied upon as set forth above. The difference between the prior art and the claims at issue is that none of these references specifi-cally discusses the stages of kidney disease in Table 1 of applicant’s specification. This “staging” of kidney disease, however was known in the prior art. Compare Table 1 in Levey (p. 838) with Table 1 in applicant’s specification (p. 7). It would have been prima facie obvious to one of skill in the art to use the staging criteria of Levey (cited in the prior action) to assess patients when treating an FXR-mediated kidney disease as discussed above and thereby arrive at subject matter within the scope of the instant claims. One would have found using such a clinical tool as being useful for describing and assessing patient health. Disease staging as discussed in Levey is normal and customary in clinical medicine.
Claims 31-33 remain rejected under 35 U.S.C. 103 as being unpatentable over Roche, Levi, Masaoutis, and Li applied above, and further in view of WO 2021188690 A1 by Song et al.
The disclosures of Roche, Levi, Masaoutis, and Li are relied upon as set forth above. The difference between the prior art and the claims at issue is that none of these references specifi-cally discloses treating Alport’s syndrome. Song (cited in the prior action), however, discloses (para. 00215) that Alport syndrome is yet another disease that was known in the prior art to be treatable with a FXR agonist. Using known FXR agonists (e.g., Roche) in accordance with their known pharmacological properties (Song) within the meaning of new claims 31033 would there-fore have been prima facie obvious. See MPEP 2144.07 Art Recognized Suitability for an Intended Purpose.
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 possi-ble 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 applica-tions subject to examination under the first-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-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 accompa-nied 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(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 that 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/terminaldisclaimer.
Claims 16 and 18-30 remain rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of Patent No. 12,030,861 B1. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘861 Patent (cited in the prior action) claims a salt of 4-chloro-5-[4-(2,6-dichlorophenyl) sulfonylpiperazin-1-yl]-1-benzofuran-2-carboxylic acid, as well as methods of using the compound in a variety of chronic renal diseases also recited in the instant claims. See, e.g., claims 1, 13, and 15 of the ‘861 Patent.
Conclusion
THIS ACTION IS MADE FINAL. 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 Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
May 6, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024].
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