DETAILED ACTION
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 .
Priority
This application is a national stage entry of PCT/EP2022/052649 filed on 02/03/2022.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in United Kingdom on February 10, 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 5-9, 14, 21, 23-26, 35 and 37) drawn to a method of treating or preventing a kidney disease in a subject, wherein the kidney disease is Chronic Kidney Disease (CKD) or an underlying condition leading to Chronic Kidney Disease (CKD), wherein the method comprises administering to the subject a compound of formula (I) or a pharmaceutically acceptable salt and/or hydrate thereof in the reply filed on February 4, 2026 is acknowledged. Applicant’s election without traverse of Chronic Kidney Disease (CKD) as a species of a kidney disease in the reply filed on February 4, 2026 is also acknowledged.
Claims 6, 40, 42, 45, 48 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 1, 2, 5, 7-9, 14, 21, 23-26, 35 and 37 are being examined as they read on the elected species.
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.
Claims 1, 2, 5, 7-9, 14, 21, 23-26, 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Alimardanov et al. U.S. Publication No. 2008/0188545 A1 in view of Feinstein et al. WO 2010/144336 A2.
The cited claims of the instant application claim a method of treating or preventing a kidney disease in a subject, wherein the kidney disease is Chronic Kidney Disease (CKD) or an underlying condition leading to Chronic Kidney Disease (CKD), wherein the method comprises administering to the subject a compound of formula (I) or a pharmaceutically acceptable salt and/or hydrate thereof having the following structure:
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also known as danegaptide.
Alimardanov et al. teaches that compound (2S,4R)-1-(2-aminoacetyl)-4-benzamidopyrrolidine-2-carboxylic acid having the following structure:
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restores and maintains the gap junction integrity between cell membranes and is useful for the treatment of diseases associated with abnormal gap junction intercellular communications [0007].
Alimardanov et al. teaches a method for treating a condition such as Type I or Type II diabetes; diabetic retinopathy; diabetic neuropathy; atherosclerosis; as well as kidney diseases, comprising administering to a patient a therapeutically effective amount of the compound described therein or a pharmaceutical formulation described therein [0071] [0347]. Alimardanov et al. teaches that examples of conditions which can be treated or prevented using compounds and pharmaceutical formulations described therein include, diabetes (Type I or Type II) and diabetic complications (including diabetic retinopathy and diabetic neuropathy); and kidney diseases [0351].
Alimardanov et al. further teaches compounds and pharmaceutical formulations described therein can be used to cytoprotect a tissue or organ of a mammal in need of such treatment, wherein cytoprotecting refers to reducing, preventing or alleviating symptoms associated with unwanted cell swelling [0355]. Alimardanov et al. teaches that particular tissues and organs that will benefit from the method include those confined or otherwise impacted by a fibrous capsule such as heart or kidney [0355].
Alimardanov et al. further teaches compounds and pharmaceutical formulations described therein can be used to prevent or treat ischemic injury in the organs of a mammal in need of such treatment, including, for example, the heart, central nervous system, kidney, gastrointestinal tract, liver, lungs, and limbs [0356].
Alimardanov et al. further teaches that the compositions can be formulated for oral administration (including buccal cavity or sublingually) or by parenteral administration (including intravenous (i.v.), subcutaneous (s.c.), intramuscular (i.m.), intraperitoneal (i.p.) administration [0339].
Alimardanov et al. further teaches that the therapeutically effective amount of the compound is at least about 100 mg/kg body weight/day, at least about 300 mg/kg body weight/day, and at least about 1000 mg/kg body weight/day [0345]. In some embodiments, the compounds are administered in the range from about 1 mg to about 1000 mg per patient per day, from about 10 mg to about 100 mg per patient per day, or about 50 mg per patient per day [0345].
Alimardanov et al. further teaches administration to a subject in need thereof which is a human being [0347].
Claim 99 of Alimardanov et al. specifically claim a method of treating a condition such as kidney disease comprising administering a therapeutically effective amount (2S,4R)-1-(2-aminoacetyl)-4-benzamidopyrrolidine-2-carboxylic acid hydrochloride.
Alimardanov et al. does not specifically exemplify the treatment of kidney disease. Alimardanov et al. does not specifically teach chronic kidney disease.
Although Alimardanov et al. does not specifically exemplify the treatment of kidney disease, Alimardanov et al. specifically teaches and claims the treatment of kidney disease; teaches the compounds and pharmaceutical formulations described therein can be used to prevent or treat ischemic injury in the organs of a mammal in need of such treatment, including, for example, the kidney; and teaches that particular tissues and organs that will benefit from the method include those confined or otherwise impacted by a fibrous capsule such as heart or kidney. Accordingly, a person of ordinary skill in the art would have been motivated to treat kidney disease based on the teachings of Alimardanov et al. with a reasonable expectation of similar success as the other conditions described therein. Thus although Alimardanov et al. includes kidney disease on lists that include other conditions, a prima facie case of obviousness can still be established since picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
Although Alimardanov et al. does not specifically teach chronic kidney disease, Alimardanov et al. specifically teaches the treatment and prevention kidney disease and thus both chronic and acute kidney diseases are contemplated by the teachings Alimardanov et al. which teaches the treatment and prevention of kidney disease in general.
Feinstein et al. teaches that chronic kidney disease (CKD) is a worldwide public health problem and is recognized as a common condition that is associated with an increased risk of cardiovascular disease and end stage renal disease (ESRD) (page 1 lines 20-23). The Kidney Disease Outcomes Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF) defines chronic kidney disease as either kidney damage or a decreased kidney glomerular filtration rate (GFR) for three or more months. In general, the destruction of renal mass with irreversible sclerosis and loss of nephrons leads to a progressive decline in GFR and eventually ESRD (page 1 lines 24-29).
The stages of CKD are as follows: Stage 1 : Kidney damage with normal or increased GFR (>90 mL/min/1.73 m2) Stage 2: Mild reduction in GFR (60-89 mL/min/1.73 m2) Stage 3: Moderate reduction in GFR (30-59 mL/min/1.73 m2) Stage 4: Severe reduction in GFR (15-29 mL/min/1.73 m2) Stage 5: Kidney failure (GFR <15 mL/min/1.73 m2 or dialysis) (page 2 lines 1-6). Feinstein et al. teaches that the two most common causes of chronic kidney disease are diabetes and hypertension (page 2 line 28). A subject at risk of chronic kidney disease (CKD) or CKD progression is a subject having any one or more of Type 1 or Type 2 diabetes mellitus, high blood pressure (hypertension), high cholesterol, heart disease, liver disease, atherosclerosis, and vascular diseases (page 4 lines 18-20).
Accordingly, prior to the effective filing date, it would have been obvious to a person of ordinary skill in the art to administer the compound of Alimardanov et al. which is danegaptide to treat or prevent chronic kidney disease since according to the teachings of Alimardanov et al., danegaptide can be used to treat kidney disease as well as conditions such as Type I or Type II diabetes; diabetic retinopathy; diabetic neuropathy; atherosclerosis; as well as other diabetes complications and Feinstein specifically teaches that diabetes is one most common cause leading to chronic kidney disease. Thus an ordinary skilled artisan would have been motivated to administer danegaptide for the treatment of diabetes with a reasonable expectation of preventing chronic kidney disease or the worsening of chronic kidney disease. In addition, since Alimardanov et al. specifically teaches that danegaptide is used in the treatment of kidney disease, an ordinary skilled artisan would have been motivated to administer danegaptide to treat chronic kidney disease and prevent worsening of the chronic kidney disease including advancing to Stage 2, 3, 4 and kidney failure.
Claims 21 and 23 are rendered obvious since Alimardanov et al. specifically teaches the administration of the same compound as claimed and thus said compound will necessarily have the same effects as claimed since a compound and its properties are inseparable. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). Claim 25 is rendered obvious since as detailed above Alimardanov et al. specifically teaches the same therapeutically effective amount as claimed and thus the same amount of the compound in the microenvironment of the renal tissues as claimed will necessarily result.
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1, 2, 5, 7-9, 14, 21, 23-26, 35 and 37 are rejected. Claims 6, 40, 42, 45, 48 and 49 are withdrawn. Claims 3, 4, 10-13, 15-20, 22, 27-34, 36, 38, 39, 41, 43, 44, 46 and 47 are canceled. No claims are allowed.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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