DETAILED ACTION
The amendment submitted on August 6, 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.
This communication includes at least one new ground for rejection that was not necessitated by amendment of the claims, nor based on information submitted in an information disclosure statement. This Office action is therefore non-final. See MPEP 706.07(a) Final Rejection, When Proper on Second Action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Withdrawn Rejections
The rejection of claims 16-18 under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0105475 A1 by Roche et al. is withdrawn because the independent claim has been amended to recite renal diseases not specifically disclosed in the reference.
Claim Rejections - 35 USC § 112
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 23-24 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 examiner appreciates that applicant has defined the renal diseases in claim 16 by incorporating the limitations of claims 19 and 25-26, but in doing so applicant has inadvertently limited the scope of claim 16 such that it no longer encompasses claims 23-24. Stated another way, claims 23-24 are impermissibly broader in scope than claim 16. 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.
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 20-22 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. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." See MPEP 2173.05(s) Reference to Figures or Tables [R-10.2019]. The reference “Table 1” in claims 20-22 is therefore indefinite.
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 and 23-30 remain rejected and new claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable 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 mate-rial 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.
Response to Arguments
Applicant argues that Levi, Li, and Masaoutis “disclose experiments concerning the preventative effects of FXR agonists” (emphasis added) and that these references do not show a reduction in existing fibrosis, only prevention. See applicant’s Remarks, submitted August 6, 2025, at pp. 8-9. This is not persuasive because Roche clearly discloses “treatment and/or prevention and/or amelioration of one or more symptoms of disease or disorders related to the activity of FXR” (see Roche Abstract, emphasis added). The evidence before the examiner indicates that one of skill in the art would have expected the compounds of the instant claims to be useful in methods of “treating.”
Applicant also argues that compounds other than those disclosed in Roche have “no significant effect” on kidney fibrosis, so it is surprising that the compounds of the instant claims have “curative effects.” Remarks at p. 9. While the examiner acknowledges that unexpected results may rebut a prima facie showing of obviousness, applicant has not persuasively done so here. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See MPEP 716.02. In this case, Roche is clearly the closest prior art because it discloses the two compounds of instant claims 17-18. Instead, applicant presents argument concerning nidufexor of obeticholic acid. See applicant’s Remarks at p. 9. As explained in the preceding paragraph, Roche discloses that the compounds disclosed therein are useful for “treating” disease, so the rejection is maintained.
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 specifically 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 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.
Response to Arguments
Applicant reiterates the arguments discussed above and asserts that this rejection should be likewise withdrawn. The rejection above, however, is maintained, so this rejection is also maintained.
New claims 31-33 are 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 specifically discloses treating Alport’s syndrome. Song, 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 therefore 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 possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined appli-cation 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 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(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 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.
Response to Arguments
Applicant argues that the ‘861 Patent was later filed and therefore the instant application would not improperly extend the life of the patented subject matter. Applicant also incorrectly states that “expiration dates are the controlling factor for nonstatutory double patenting for applications such as the instant application.” Remarks at p. 10. In addition to patent term, another policy objective is “to prevent possible harassment by multiple assignees,” so it is not just patent term that matters. Current Office policy, explained in MPEP 804, is to require a terminal disclaimer for patentably indistinct inventions. The rejection is therefore maintained.
Conclusion
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 examiner can normally be reached Monday - Thursday, 7:00 am - 6:00 pm (Eastern Time).
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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
November 17, 2025
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024].