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 .
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.
Current Status of 19/024,516
This Office Action is responsive to the original claims received 16 January 2025.
Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications 63/693,267 (filed 11 September 2024) and 63/621,182 (filed 16 January 2024) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) received on 16 July 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: There is a period that occurs after the penultimate chemical structure in the claim. This is grammatically incorrect. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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 5, 8, and 18-20 are 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.
Claim 5 recites “(including ischemic, viral, and diabetic cardiomyopathy)” within parentheses. This use of parentheses causes it to be unclear to the reader whether this limitation is exemplary or required. This renders claim 5 indefinite. Applicant may choose to make each of the types of cardiomyopathy a separate item within the list.
Claim 8 recites “the pharmaceutically acceptable vehicle”, but this term was not previously introduced in this claim or a parent claim. Therefore, this term lacks antecedent basis and claim 8 is rendered indefinite. Applicant may choose to amend claim 8 such that it depends upon claim 7.
Claims 18-20 each recite the “use” of a compound of claim 1 to treat or mitigate a condition without providing any steps involved in these processes. A claim of this type is held to be indefinite “because it merely recites a use without any active, positive steps delimiting how this use is actually practiced.” Ex parte Erlich, 3 USPQ2d 1011. See MPEP 2173.05(q). This renders claims 18-20 indefinite.
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 2-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
BIDEVKINA (Bidevkina, M.V.; Golubeva, M.I., Rozhnov, G.I.; et al. “N-phthaloyl-5-benzyloxytryptamine. 2-[2-[5-(phenylmethoxy)-1H -indole-3-yl]ethyl]-1H-isoindole-1,3(2H)dione” Toksikologicheskii Vestnik , 2006, (3), p.41-42).
BIDEVKINA teaches that 2-[2-[5-(phenylmethoxy)-1H -indole-3-yl]ethyl]-1H-isoindole-1,3(2H)dione, being identical to compound 6 of instant claim 2, was administered intravenously to rats at a dose of 500 mg/kg, and this did not causes any changes in body weight after 8 days. One of ordinary skill in the art would understand that BIDEVKINA is teaching the administration of an aqueous solution of the compound named above, not somehow injecting powder, and this injection solution taught by BIDEVKINA anticipates the pharmaceutical composition claimed within instant claim 2.
Regarding claims 3: The outcome within instant claim 3 is solely the result of administering the pharmaceutical composition of claim 2 to a subject. There are no positive steps recited therein that would alter this outcome unrelated to administering the pharmaceutical composition of claim 2 to the subject. Therefore, because the method of administering the pharmaceutical composition of claim 2 to the subject has been found to be anticipated, this direct outcome must also be anticipated.
Regarding claims 5-6: The limitation “for the treatment and/or mitigation of one or more of” from claim 5 and “for providing cardioprotection” of claim 6 are interpreted as intended use limitations. Nothing precludes these uses as claimed. Therefore, as BIDEVKINA anticipates claim 2, BIDEVKINA necessarily anticipates claims 5-6.
Regarding claims 9-10: BIDEVKINA teaches the administration of 500 mg/kg doses to rats. The rats are also described as weighing 230 g by BIDEVKINA. Therefore, the reader is taught to administer 115 mg of the compound therein to a 230 g rat.
Regarding claim 11: BIDEVKINA provides a limit for the concentration of the compound therein in drinking water, which one of ordinary skill in the art would have understood indicates human drinking water.
Claim Rejections - 35 USC § 103
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over:
HARTER (US 7,498,460 B2, Date of Patent 3 March 2009).
HARTER generally teaches compounds intended to treat cardiovascular disorders (abstract). Column 47 of HARTER teaches the compound shown below, referred to as Example XXIII therein. HARTER teaches compound XXIII to be useful for the synthesis of therapeutic compounds, including exemplary compound 116 in column 135. Compound XXIII differs from the instantly claimed compound 5 only by the butyl linker at the left side of the molecule below; the instantly claimed compound contains a propyl linker.
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Claim 7 of HARTER refers to compounds with the general structure of Example XXIII above as compounds of formula (IVa). The instantly claimed compound 5 falls within the scope of formula (IVa) of claim 7 of HARTER. Claim 3 of HARTER teaches that the same linker relevant to this discussion (referred to as L) can be a bivalent methanediyl, n-propanediyl, or n-butanediyl group (Col. 186, Ln. 41). Propyl linkers are also expressly shown in compounds present in HARTER, such as Example XIX below, copied from column 45 of HARTER.
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It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to read the teachings of HARTER and to have immediately envisaged the replacement of the alkyl linkers therein with slightly longer and shorter alkyl linker units, for the purpose of tuning the therapeutic effect of the compounds of HARTER. Upon seeing compound the Example XXIII of HARTER, the artisan would have immediately envisaged the replacement of the left-most alkyl linker with a propyl group and other simple alkyl groups, producing the instantly claimed compound 5. The artisan would have expected success in this alkyl linker replacement, because it is taught within a list of three proposed linker moieties within claim 3 of HARTER.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
