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 .
DETAILED ACTION
Priority and Status of Claims
1. This application is a CON of 17540638 12/02/2021 PAT 11969422, which claims benefit of 63/123,728 with a filing date 12/10/2020.
2. Claims 21-40 are pending in the application.
Double Patenting
3. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
3.1 Claims 21-22 and 31-32 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claims 1-2 and 10-11 of Patel et al. US 11,969,422, over claims 1 and 3 of Levin et al. US10,953,102, over claim 1 of Levin et al. US 10,556,013, and over claim 1 of Levin et al. US 11,376,330. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a method of treating heart failure in a subject with a left ventricular ejection fraction (LVEF) of below 50%, the method comprising providing to a subject having heart failure with an LVEF of below 50% a compound represented by formula (X),
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, or a pharmaceutically acceptable salt thereof, wherein
the specific conditions selected from aortic stenosis, arrhythmia, cerebrovascular
accident, chronic obstructive pulmonary disease, cigarette smoking, congenital heart
disease, diabetic cardiomyopathy, dilated cardiomyopathy, hypertension, or ischemic
coronary disease, see claims 21-22.
Applicants claim a method of treating heart failure in a subject with a left ventricular
ejection fraction (LVEF) of below 50%, the method comprising providing to a subject
having heart failure with an LVEF of below 50% a compound represented by formula
(IX),
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, or a pharmaceutically acceptable salt thereof,
wherein the specific conditions selected from aortic stenosis, arrhythmia,
cerebrovascular accident, chronic obstructive pulmonary disease, cigarette smoking,
congenital heart disease, diabetic cardiomyopathy, dilated cardiomyopathy,
hypertension, or ischemic coronary disease, see claims 31-32.
Patel et al. ‘422 claims a method of treating heart failure associated with reduced
ejection fraction (HFrEF) in a subject, the method comprising providing to a subject
having HFrEF a compound represented by formula (X):
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or a pharmaceutically acceptable salt thereof, see claim
1. Dependent claim 2 further limit the scope of methods, i.e., specific conditions
selected from congenital heart disease, aortic stenosis or hypertension or dilated
cardiomyopathy, see column 15.
Patel et al. ‘422 claims a method of treating heart failure associated with reduced
ejection fraction (HFrEF) in a subject, the method comprising providing to a subject
having HFrEF a compound represented by formula (IX),
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, wherein the condition is selected from aortic
stenosis, arrhythmia, cerebrovascular accident, chronic obstructive pulmonary disease,
cigarette smoking, congenital heart disease, diabetic cardiomyopathy, dilated
cardiomyopathy, hypertension, or ischemic coronary disease, see column 16.
Levin et al. ‘102 claims a method of increasing cardiac efficiency in a subject, the method comprising providing to a subject a compound represented by formula (X):
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, wherein the subject has heart failure, thereby increasing cardiac efficiency in the subject, see columns 58-60.
Levin et al. ‘013 claims a compound by formula (X), i.e.,
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, see column 58. Levin et al. ‘013 compound is used for treating heart failure, see column 10.
Levin et al. ‘330 claims a HCl salt of a compound by formula (X), i.e.,
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, see column 58. Levin et al. ‘330 compound is used for treating heart failure, see column 10.
The difference between instant claims and Patel et al. ‘422, Levin et al. ‘102, ‘013 and ‘330 is that Patel et al. ‘422, Levin et al. ‘102, ‘013 and ‘330 are silent on the instant LVEF. The instant methods of use are embraced within the scope of Patel et al. ‘422, Levin et al. ‘102, ‘013 and ‘330.
One having ordinary skill in the art would find the claims 21-22 and 31-32 prima facie obvious because one would be motivated to employ the methods of use of Patel et al. ‘4222, Levin et al. ‘102, ‘013 and ‘330 to obtain instant invention.
Additionally, the discovery of a new property or use, i.e., with left ventricular ejection fraction (LVEF) of a previously known compounds and methods of use for treating heart failure of Patel et al. ‘422, Levin et al. ‘102, ‘013 and ‘330, even when that property and use are unobvious from the prior art, cannot impart patentability to claims to the known compounds, see In re Spada, 15 USPQ2d 1655 (Fed. Cir. 1990), and MPEP 2112.01. Therefore Patel et al. ‘422, Levin et al. ‘102, ‘013 and ‘330 renders obviousness over the instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Patel et al. ‘422, Levin et al. ‘102, ‘013 and ‘330 would possess similar activity to that which is claimed in the reference.
3.2 Claims 21-22 and 31-32 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable independently over claim 1 of Patel et al. US 11,730,733, over claims 1 and 12 of Patel et al. US11,793,807, over claims 1 and 10 of Patel et al. US 12,076,318 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a method of treating heart failure in a subject with a left ventricular ejection fraction (LVEF) of below 50%, the method comprising providing to a subject having heart failure with an LVEF of below 50% a compound represented by formula (X),
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, or a pharmaceutically acceptable salt thereof, wherein
the specific conditions selected from aortic stenosis, arrhythmia, cerebrovascular
accident, chronic obstructive pulmonary disease, cigarette smoking, congenital heart
disease, diabetic cardiomyopathy, dilated cardiomyopathy, hypertension, or ischemic
coronary disease, see claims 21-22.
Applicants claim a method of treating heart failure in a subject with a left ventricular
ejection fraction (LVEF) of below 50%, the method comprising providing to a subject
having heart failure with an LVEF of below 50% a compound represented by formula
(IX),
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460
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, or a pharmaceutically acceptable salt thereof,
wherein the specific conditions selected from aortic stenosis, arrhythmia,
cerebrovascular accident, chronic obstructive pulmonary disease, cigarette smoking,
congenital heart disease, diabetic cardiomyopathy, dilated cardiomyopathy,
hypertension, or ischemic coronary disease, see claims 31-32.
Patel et al. ‘733 claims a method of treating non-obstructive hypertrophic cardiomyopathy (HCM) (i.e., heart failure) in a subject, the method comprising providing to a subject having non-obstructive HCM a compound represented by formula (X):
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, or a pharmaceutically acceptable salt thereof, see
columns 17-18.
Patel et al. ‘807 claims a method of treating heart failure associated with preserved
ejection fraction (HFpEF) in a subject, the method comprising providing to a subject
having HFrEF a compound represented by formula (X):
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, or a pharmaceutically acceptable salt thereof, see
Claim 1 in column 13-14.
Patel et al. ‘807 claims a method of treating heart failure associated with preserved
ejection fraction (HFpEF) in a subject, the method comprising providing to a subject having
HFpEF a compound represented by formula (IX),
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, or a pharmaceutically acceptable salt thereof, see
Claim 12 in column 14.
Patel et al. ‘318 claims a method of reversing hibernating myocardium in a subject with heart failure, the method comprising providing to a subject with hibernating myocardium a compound represented by formula (X),
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, or a pharmaceutically acceptable salt thereof, see claim
1 in columns 14-15..
Patel et al. ‘318 claims a method of reversing hibernating myocardium in a subject with heart failure, the method comprising providing to a subject with hibernating myocardium a compound represented by formula (IX)
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, or a pharmaceutically acceptable salt thereof, see
claim 10 in column 16..
The difference between instant claims and Patel et al. ‘733, ‘807 and ‘318 is that Patel et al. ‘657, ‘653 and ‘646 are silent on the instant LVEF. The instant methods of use are embraced within the scope of Patel et al. ‘733, ‘807 and ‘318.
One having ordinary skill in the art would find the claims 21-22 and 31-32 prima facie obvious because one would be motivated to employ the methods of use of Patel et al. ‘733, ‘807 and ‘318 to obtain instant invention.
Additionally, the discovery of a new property or use, i.e., with left ventricular ejection fraction (LVEF) of a previously known compounds and methods of use for treating heart failure of Patel et al. ‘733, ‘807 and ‘318, even when that property and use are unobvious from the prior art, cannot impart patentability to claims to the known compounds, see In re Spada, 15 USPQ2d 1655 (Fed. Cir. 1990), and MPEP 2112.01. Therefore Patel et al. ‘733, ‘807 and ‘318 renders obviousness over the instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Patel et al. ‘733, ‘807 and ‘318 would possess similar activity to that which is claimed in the reference.
Claim Objections
4. Claims 23-30 and 33-40 are objected to as being dependent on rejected claims 21 and 31.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
May 18, 2026
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