Detailed Action
The present office action is in response to the reply filed on 20 Jul 2026.
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 .
Status
Claims 28-31 and 33-40 of the pending application have been examined on the merits. Claim 32 is withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the cancellation of claims 1-27.
Priority
Applicants identify the instant application, Serial #: 18/618,124, filed 27 Mar 2024, as a Continuation of U.S. Application #s: 17/206,955, filed 19 Mar 2021, and 16/522,116, filed 25 Jul 2019, which claims foreign priority from foreign application #: EP18185871.3, filed 26 Jul 2018.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 24 Oct 2024, 26 Jun 2025, and 02 Sep 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Elections
Applicant’s election of Alport syndrome as the species of kidney disease and 5-(3,4-dichloro-phenyl)-N-((1R,2R)-2-hydroxy-cyclohexyl)-6-(2,2,2-trifluoro-ethoxy)-nicotinamide as the species of compound in the reply filed on 20 Jul 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). No prior art was found after a search for the elected invention. The Markush search was expanded to include focal segmental sclerosis as the species of kidney disease. A search for FSGS returned prior art.
Claim 32 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 Jul 2026.
Examiner notes that the relevant anticipation rejection below is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species where the elected compound is used to treat kidney disease. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim Objections
Claim 36 is objected to because of the following informalities: The phrase, “wherein the daily dose the ABCA1 inducer,” should be, “wherein the daily dose of the ABCA1 inducer.” Appropriate correction is required.
Claim 38 is objected to because of the following informalities: The word “double” should be “doubles”. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: The formatting separating the elements of the Markush group is not standardized. Both semi-colons and commas are used to separate the elements of the list. Applicant may overcome this rejection by standardizing the formatting of the claims. Appropriate correction is required.
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 28-31 and 33-40 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.
Regarding claim 28-31 and 33-40, claim 28 is directed towards a “method for treating kidney disease in a subject in need thereof, comprising administering a therapeutically effective amount of an ABCA1 inducer compound…” It is unclear where the ABCA1 inducer compound is being administered. Claims 29-31 and 33-40 are rejected for failing to remedy the deficiencies of claim 28. Applicant may overcome this rejection by amending the claims to recite a subject that the ABCA1 inducer compound is administered to.
Regarding claim 38, the claim is directed to the method of treating kidney disease by administering a ABCA1 inducer compound selected from
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wherein the loading dose regimen doubles the dose for the first 7 days, 14 days, or 30 days. However, “the loading dose regimen” lacks antecedent basis. Applicant may overcome this rejection by amending the claim to have proper antecedent basis to the independent claim.
Further, it is unclear whether the loading dose regimen doubles the dose every day for the first 7 days, 14 days, or 30 days, or if double the normal dose is administered for the first 7 days, 14 days, or 30 days. Applicant may overcome this rejection by clarifying the claim language.
Regarding claim 39, the phrase "like" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following anticipation rejection is based upon art which was found incidental to the search for the elected species. The additional art found is relevant to the claims addressing species where the elected compound is used to treat kidney disease. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim(s) 28-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014/180741, hereinafter ‘741.
The instant claims 28-29 are directed to a method of treating kidney disease by administering an ABCA1 inducer compound selected from:
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‘741 teaches Compound B and Compound E which align with instant compound G and A, respectively (pgs. 22-23).
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‘741 further teaches treatment of diseases, including diabetes, by administering compounds of the reference (Abstract and pg. 8). Diabetes is a kidney disease and so the reference anticipates the instant claims.
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.
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. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 28-31 and 33-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘741 further in view of WO 2011/029827, hereinafter ‘827, and Tae-hyun (“Elucidation of mechanisms of lipid metabolism abnormalities in podiacytes and exploration of therapeutic drugs.” https://scienceon.kisti.re.kr/srch/selectPORSrchReport.do?cn=TRKO201900001750, Accessed 05 Sep 2026, published 17 Dec 2017), hereinafter Tae-hyun.
The instant claims 28-31 are directed to a method of treating kidney disease by administering an ABCA1 inducer compound selected from:
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Applicant has elected Compound G as the species of compound and Alport syndrome as the species of kidney disease. The Markush search for species of kidney disease was expanded to include focal segmental sclerosis. The claims further narrow the formulation of the ABCA1 inducer (claims 33-34), the amount of ABCA1 inducer administered (claims 35-36), and the dosing regimen of the ABCA1 inducer (claims 37-38). Claims 39-40 are directed to further administering another therapeutic compound to treat kidney disease.
‘741 teaches Compound B and Compound E which align with instant compound G and A, respectively (pgs. 22-23).
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‘741 further teaches treatment of diseases, including diabetes, by administering compounds of the reference (Abstract and pg. 8). ‘741 teaches that the molecules of the reference, useful as OSBPL7 targeting compounds, would be useful as medicaments for the treatment and/or prophylaxis of diseases associated with ABCA1 (pg. 2, lines 28-32). However, ‘741 does not teach treating Alport syndrome by administering reference Compound B to a subject in need. ‘741 further does not teach the instantly claimed formulations of reference Compound B.
‘827 teaches isomeric form Ia is 5-(3,4-dichloro-phenyl)- N-((1R,2R)- 2-hydroxy-cyclohexyl)-6-(2,2,2-trifluoro-ethoxy)-nicotinamide which aligns with reference Compound B of ‘741 and the instantly elected Compound G (pg. 3, lines 23-26). ‘827 teaches the reference compounds may be formulated for topical, oral, or parenteral administration (pg. 9, lines 15-21). ‘827 further teaches that a therapeutically effective amount or dosage of the reference compounds can vary within wide limits depending on the disease to be controlled, the age and the individual condition of the patient, and the mode of administration, and will, of course, be fitted to the individual requirements in each particular case (pg. 10, lines 10-13). The reference compounds can be formulated in doses from 1 mg to 100 mg and administered in 1-3 daily doses, which encompasses the instantly claimed 200 mg (pg. 10, lines 13-16).
Tae-hyun teaches that deficient ABCA1 and PCSK9 in diabetic nephropathy and FSGS play a pathophysiologic mechanisms for podocyte damage and development of proteinuria (pg. 3, Expected Contribution). Tae-hyun further teaches that the ABCA1 agonist LXR reversed podocyte damage in an FSGS mouse model and that ABCA1 has therapeutic potential as a target for treating FSGS and diabetic nephropathy (pg. 3, pg. 20, pg. 28, and pg. 32)
Based on the teachings of ‘741 and Tae-hyun, the artisan would treat FSGS mouse models with reference Compound B to reverse podocyte damage caused by decreased ABCA1 expression. The artisan would be motivated to treat FSGS in this manner based on the teaching of Tae-hyun that ABCA1 represents a viable therapeutic target to reverse podocyte damage.
It would be obvious to the artisan to formulate the reference Compound B as a topical, oral, or parenteral solution and that it would be within the skill of the artisan to choose a dosage and formulation to treat ABCA1-mediated diseases based on the variables of the patient and disease, as taught by ‘741 and ‘827.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 28-29 are rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 13, 15, 17, and 19 of U.S. Patent No. 12,134,599. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims 28-29 are directed to a method of treating kidney disease by administering an ABCA1 inducer compound selected from:
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The reference patent claims crystalline forms of instant Compound G (ref claims 1, 3, 5, and 7) and further teaches treating kidney disease in a patient in need by administering the crystalline forms of instant Compound G (ref claims 13, 15, 17, and 19). Therefore, the reference patent overlaps with the instant claims.
Claims 28-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9, and 16 of U.S. Patent No. 11,814,354. Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference patent claims a crystalline form of instant Compound G (ref claim 1) and further teaches treating kidney disease in a patient in need by administering the crystalline forms of instant Compound G (ref claim 16). Therefore, the reference patent overlaps with the instant claims.
Claim 28-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-23 of copending Application No. 18/898,885 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference application claims a method of treating kidney disease in a patient by administering a crystalline form of instant Compound G to the patient (ref claims 22-23). Therefore, the reference patent overlaps with the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.M./Examiner, Art Unit 1625
/Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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