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
Claims 1, 2, 5, 7, 9, 11, 12, 18-26, 28-30 and 32 are currently pending in the instant application. Applicants have amended claims 2, 5, 7, 9, 11, 12, 18-21, 24, 26, 29, 30, 32 and canceled claims 3, 4, 6, 8, 10, 13-17, 27, 31 and 33-46 in an amendment filed on May 29, 2024. Claims 1, 7, 9, 11, 12, 18-25, 29, 30 and 32 are rejected and claims 2, 5, 26 and 28 are objected in this Office Action.
I. Priority
The instant application is a 371 of PCT/US2022/080708, filed on November 30, 2022 which claims benefit of US Provisional Application 63/285,298, filed on December 2, 2021.
II. Information Disclosure Statement
The information disclosure statements (IDS) submitted on May 29, 2024 and June 18, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
III. Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 12, 19, 30 and 32, 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 claims 12, 19, 30 and 32, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicants are suggested to delete the limitations that include the phrase “preferably” to overcome the rejection.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 32 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The phrase “Use of a compound…” is written in improper format because a “use” can only be properly claimed as a process or method. It is suggested that applicant amend the claims by rewriting the claims as a process or method, i.e. “a method of preparing…”
35 USC § 103 - OBVIOUSNESS REJECTION
The following is a quotation of 35 U.S.C. § 103(a) that forms the basis for all
obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Graham v. John Deere Co. set forth the factual inquiries necessary to determine obviousness under 35 U.S.C. §103(a). See Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Specifically, the analysis must employ the following factual inquiries:
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.
Claims 1, 7, 9, 11, 12, 18, 20-25, 29, 30 and 32 are rejected under 35 U.S.C. § 103 as being unpatentable over Carlson, et al. (WO 2021/092598 A1). Applicants claim
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The Scope and Content of the Prior Art (MPEP §2141.01)
Carlson, et al. teaches compositions that are useful in treating a heart disease or treating a disease wherein the subject is suffering from diastolic dysfunction, left ventricular hypertrophy, angina, ischemia, hypertrophic cardiomyopathy, restrictive cardiomyopathy or heart failure with preserved ejection fraction (HFpEF) (see paragraph [020], page 4). The invention is a composition comprising a myosin modulator being used in the treatment and further comprising a step of administering to the subject a therapeutic dose of a beta adrenergic agonist which could be an infusion from about 0.2 to about 0.4 μmol/kg of levosimendan over a period of about 30 minutes (see paragraph [054], page 9). The prior art also teaches that another additional agent that can be used in the composition could be a SGLT2 inhibitor such as empaglifozan, dapagliflozin or sotagliflozin (see paragraph [373], page 60).
The Difference Between the Prior Art and the Claims (MPEP §2141.02)
The difference between the prior art of Carlson, et al. and the instant invention is that the instant invention specifically teaches a composition comprising levosimendan and a SGLT2 inhibitor for treating heart failure whereas the prior art broadly teaches that individually that levosimendan is used in combination with a myosin inhibitor to treat heart failure and a SGLT2 inhibitor can be used in combination with a myosin inhibitor to treat heart failure. The prior art broadly teaches that combinations of different additional therapeutic agents can be used to treat heart failure but does not specifically teach a composition comprising levosimendan and a SGLT2 inhibitor as seen in the instant claimed invention.
Prima Facie Obviousness-The Rational and Motivation (MPEP §2142-2413)
In In re Kerkhoven, 626 F. 2d 846, 205 USPQ 1069 (CCPA 1980), it was well established that it is obvious to combine individual compositions taught to have the same utility to form a new composition for the very same purpose. Both levosimendan and SGLT2 inhibitors have been taught in the prior art individually as additional therapeutic which could be used to treat heart diseases such as heart failure. Therefore, it would be within one of ordinary skill in the art to prepare a composition comprising both therapeutic agents, levosimendan and SGLT2 inhibitors, for treating a heart failure with a reasonable expectation for success.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to prepare compositions comprising levosimendan and SGLT2 inhibitors for the purpose of treating heart failure based on the teachings of the preferred embodiments in the prior art since both agents are taught individually as being useful in treating heart failure. A strong prima facie obviousness has been established.
V. Objections
Dependent Claim Objections
Dependent Claims 2, 5, 26 and 28 are objected to as being dependent upon a rejected based claim. To overcome this objection, Applicant should rewrite said claims in an independent form and include the limitations of the base claim and any intervening claim.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is 571-272-9043. The examiner can normally be reached on 7:00 AM-3:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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