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
The instant claims are a CON of application 17/612,468 filed 18 November 2021 which is the national stage entry of PCT/US2020/033438 filed 18 May 2020. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US applications 62/852,736 filed 24 May 2019, 62/852,739 filed 24 May 2019, and 62/849,936 filed 19 May 2019. The effective filing date of the claims is 19 May 2019.
Status of the Claims
Claims 54-73 are pending.
Claims 54-73 are rejected.
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.
Claims 54-58, 60-63, and 67-73 are rejected under 35 U.S.C. 103 as being unpatentable over Oslob at al. (WO 2016/118774).
Oslob teaches compounds of Formula I, or a salt thereof, which comprises the following structure reading on the structure of the instant claims [0044].
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The above agent can be used in a pharmaceutical composition for treating dilated cardiomyopathy (DCM), which is non-ischemic, in humans [0003, 0047] wherein the active agent is included in an amount sufficient to increase myocardial contractility (i.e. improve systolic dysfunction in DCM) and improve left ventricular relaxation [0048]. DCM refers to non-ischemic primary diseases of the myocardium [0003]. The composition can be in solid form and administered in oral dosages such as a tablet [0049]. Regarding the method of treatment, the compounds of Oslob are believed to bind directly to mutant sarcomeric proteins and correct for their aberrant function [0059]. Additionally, these compounds increase systolic function and can treat a wide range of disorders attributed to systolic dysfunction (left or right sided heart failure) or a reduction in systolic reserve (HFpEF) [0059]. In addition, the compounds of Oslob can confer benefits to patients suffering from heart failure with reduced ejection fraction (HFrEF), chronic congestive heart failure, idiopathic dilated cardiomyopathy, and can promote salutary ventricular reverse modeling of left ventricular dysfunction due to ischemia such as chronic mitral regurgitation [0061]. Regarding the dosage, the compounds of Oslob can be administered once or twice daily in total oral dosages of from 25-300 mg [0063].
Oslob does not teach a single embodiment of the claimed composition.
It would have been prima facie obvious to prepare the composition of Oslob comprising Compound I of the instant claims and a beta blocker wherein the agents are formulated as an oral tablet comprising from 25-300 mg of active. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of active agents and dosage forms from within Oslob, to arrive at compositions “yielding no more than one would expect from such an arrangement.” The resulting composition would have been obvious to use in a method of treating (non-ischemic) dilated cardiomyopathy (DCM) or systolic dysfunction wherein the patient is suffering from heart failure with HFrEF wherein the HFrEF is associated with dilated cardiomyopathy or acute heart failure. The patient can also exhibit mitral regurgitation. Since Oslob teaches that patients with left ventricular ejection fraction of less than 30% can reduce sudden arrhythmic death, it would have been obvious to treat a patient so that the fraction is 30% or less.
Claims 54-58, 60-63, and 67-73 are accordingly rejected as obvious in view of the prior art.
Claims 54-73 are rejected under 35 U.S.C. 103 as being unpatentable over Oslob at al. (WO 2016/118774) in view of Lowes (US 2012/0172251) in view of Seidman et al. (US 2014/0199284).
Oslob, as applied supra, is herein applied in its entirety for the teachings of a method of orally treating dilated cardiomyopathy with a composition comprising Compound I.
Oslob does not teach wherein the subject has NYHA Class II-IV heart failure symptoms nor does it teach that the DCM is associated with genetic mutation in a gene.
Lowes teaches about a study that was performed on patients with idiopathic dilated cardiomyopathies as well as NYHA class II-IV symptoms of heart failure [0114].
Seidman teaches that the TTN gene is implicated in cardiomyopathy [0005]. Mutations in the TTN gene sequence are associated with increased risk of having or developing DCM and/or heart failure
It would have been prima facie obvious to prepare the composition of Oslob comprising Compound I of the instant claims wherein the agent is formulated as an oral tablet comprising from 25-300 mg of active for the treatment of non-ischemic DCM. Moreover, it would have been obvious to administered the composition to subjects with TTM gene mutations since they are at higher risk of developing DCM and heart failure. In addition, it would have been obvious to administer Compound I to subjects with both idiopathic dilated cardiomyopathies as well as NYHA class II-IV symptoms of heart failure, since Lowes teaches that it is possible to have these occurring at the same time in a subject. The resulting method renders obvious instant claims 54-73.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
