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
Pursuant to the preliminary amendment dated 5/12/2024, claims 1-54 are canceled and claims 55-74 are newly added.
Claims 55-74 are pending in the instant application and are examined on the merits herein.
Priority
The application is a National Stage entry of PCT/IL2022/051306 filed on 12/12/2022, which claims priority to provisional application 63/265588 filed on 12/17/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 7/16/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Interpretation
With respect to claim 74, reciting, “A de-hydroxy cardiac steroid.”, the specification is considered for guidance on claim scope. The specification describes de-hydroxy cardiac steroids as having the following structure:
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, where R=a 5- or 6-membered lactone. (pp. 3-4) The specification also states that, “a cardiac steroid is an organic compound that is medicinally useful in increasing rate of contractions and output force of the heart by interacting with Na⁺, K⁺ -ATPase”. (p. 4) Based on the description in the specification, the scope of claim 74 is interpreted to encompass any compound having the core structure as depicted above. Moreover, compounds having this core structure will necessarily modulate Na+/K+ ATPase activity, by falling into the class of cardiac steroids.
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.
Claims 59, 60 and 70-74 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 59 depends from claim 60 and claim 60 depends from claim 59. This renders the scope of the claims indefinite because neither dependent claim depends from an independent claim.
Claims 70-74 contain, or depend from claims that contain, parenthetical statements. The use of parenthetical statements renders the claim indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention or meant as options or examples. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation(s) will be considered without taking into account parenthetical statements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 55-58, 61-65, 67, 69 and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kruger et al. (US 4,102,884 A; 1978, IDS).
Kruger et al. discloses 14-hydroxy-19-nor-5β,14β-carda-3,20(22)-dienolide; 14,19-dihydroxy-5β,14β-carda-3,20(22)-dienolide; 19-methoxycarbonyl-14-hydroxy-5β,14β-carda-3,20(22)-dienolide; and 19-carboxy-14-hydroxy-5β,14β-carda-3,20(22)-dienolide. (Claim 11) Kruger also discloses the following compounds: (Table 2, Claim 8)
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Kruger further discloses that the compounds are effective ATPase inhibitors and useful as heart active steroids. (Table 1, Col. 25)
With respect to claim 74, the compounds of Kruger meet the limitation of being a “de-hydroxy cardiac steroid” based in the claim interpretation section above.
Accordingly, the instant claims are anticipated by the prior art.
Claims 55-58, 61-65, 67-69 and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stidle et al. (US 3,543,307 A; 1970, IDS).
Stidle et al. discloses 5β,14β-dihydroxy-Δ3,20,22-bufatrienolide; 5β,14β -dihydroxy-19-oxo-Δ3,20,22-bufatrienolide; and 5β,14β,19-trihydroxy- Δ3,20,22-bufatrienolide. (Col. 3, Ln. 55-62; Claims 4-6; depicted below) Stidle further discloses that the compounds are cardioactive and maybe administered, as a tablet, to treat heart insufficiency. (Col. 4, Ln. 6-67)
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With respect to claim 74, the compounds of Stidle meet the limitation of being a “de-hydroxy cardiac steroid” based in the claim interpretation section above.
Accordingly, the instant claims are anticipated by the prior art.
Claims 55-58, 61-66, 68 and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gobbini et al. (Bioorg. Med. Chem., 1998, IDS).
Gobbini et al. discloses compound 10, 14β-hydroxy-5β-carda-Δ3,20,22-dienolide. (Scheme 3)
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Gobbini also discloses that cardiac glycosides are well known drugs clinically used to improve myocardial contractility in the treatment of congestive heart failure. Their action is mainly due to inhibition of Na+,K+ ATPase, an enzyme located in the cell membrane and promoting the outward transport of Na+ and the inward transport of K+. (Introduction)
With respect to claim 74, the compounds of Gobbini meet the limitation of being a “de-hydroxy cardiac steroid” based in the claim interpretation section above.
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 70-73 are rejected under 35 U.S.C. 103 as being unpatentable over Kruger et al. (US 4,102,884 A; 1978, IDS), or in the alternative over Stidle et al. (US 3,543,307 A; 1970, IDS), or in the alternative over Gobbini et al. (Bioorg. Med. Chem., 1998, IDS), in view of Boger et al. (US 2016/0143934, PTO-892)
The disclosure of Kruger or Stidle or Gobbini are referenced as discussed above. These references do not teach methods of treatment.
Boger et al. discloses that cardiac glycosides and cardiac steroids have been prescribed for centuries to treat congestive heart failure and arrhythmias, conditions in which they bind to the Na+,K+-ATPase and inhibit its activity. The number of compounds identified in animals and plants is growing and novel effects are becoming evident, including anti-cancer and anti-viral activities. (¶0002, 0022)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that any of the compounds disclosed by Kruger or Stidle or Gobbini would be effective in methods of treating heart failure, cancer or a viral infection, thereby arriving at the instant invention. One would find the use of the compounds of the prior art for treating heart failure, cancer or a viral infection reasonable because the prior art teaches that the compounds are effective Na+,K+-ATPase inhibitors and Boger teaches that cardiac steroids having Na+,K+-ATPase inhibitory activity are known to be effective for treating heart failure, cancer or viral infections.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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