DETAILED ACTION
1. Claims 1-56 are pending in the instant application.
2. Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 34-56 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating depressive disorder, premenstrual dysphoric disorder, seasonal affective disorder, psychotic depression, disruptive mood dysregulation disorder, bipolar disorder, cyclothymic disorder, anxiety disorder, does not reasonably provide enablement for treating mood disorder other than depressive disorder, premenstrual dysphoric disorder, seasonal affective disorder, psychotic depression, disruptive mood dysregulation disorder, bipolar disorder, cyclothymic disorder, anxiety disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
1) The breadth of the claims.
2) The nature of the invention,
3) The state of the prior art,
4) The level of one of ordinary skill,
5) The level of predictability in the art,
6) The amount of direction provided by the inventor,
7) The existence of working examples,
8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The nature of the invention: The instant invention is drawn to method for treating mood disorder, said method comprising administration of the compound or pharmaceutically acceptable salt thereof according to claim 1.
The state of the prior art: The state of the prior art: As indicated by the prior art, there is not any association between 5-HT2 inhibitors and treating mood disorder other than depressive disorder, premenstrual dysphoric disorder, seasonal affective disorder, psychotic depression, disruptive mood dysregulation disorder, bipolar disorder, cyclothymic disorder, anxiety disorder. There is no guidance in the prior art that 5-HT2 inhibitor could be useful to treat mood disorder other than depressive disorder, premenstrual dysphoric disorder, seasonal affective disorder, psychotic depression, disruptive mood dysregulation disorder, bipolar disorder, cyclothymic disorder, anxiety disorder.
The predictability in the art: At present using 5-HT2 to treat mood disorder other than depressive disorder, premenstrual dysphoric disorder, seasonal affective disorder, psychotic depression, disruptive mood dysregulation disorder, bipolar disorder, cyclothymic disorder, anxiety disorder is purely speculative. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. They have not shown a nexus to treat diseases but have provided only reports in vitro which, absent a correlation to treat of diseases, are not sufficient to enable the invention.
The level of the skill in the art: The level of skill in the art is high.
Amount of guidance/working examples: Applicant provides examples of the test compounds to inhibit 5-HT2 on pages 122-146. However, there is no guidance for using a therapeutically effective amount of a compound of Formula (I) to treat mood disorder other than depressive disorder, premenstrual dysphoric disorder, seasonal affective disorder, psychotic depression, disruptive mood dysregulation disorder, bipolar disorder, cyclothymic disorder, anxiety disorder.
The breadth of the claims: The claims encompass a method for treating mood disorder.
The quantity of experimentation needed: Since the guidance and teaching provided by the specification is insufficient for treating diseases associated with therapeutically effective amount of a compound of formula (I) is efficacious, one of ordinary skill in the art, even with high level of skill, is unable to use the instant compounds as claimed without undue experimentation.
Taking all of the above into consideration, it is not seen where the instant claims 34-56, for treating diseases associated with therapeutically effective amount of a compound of Formula (I) is efficacious, have been enabled by the instant specification.
3. 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 1-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stoll et al., Helvetica Chimica Acta (1943), 26, 944-65. Stoll et al. discloses the instant claimed compound, which from the STN search is
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Stoll et al.
4. Claims 1-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mayer-Gross et al., Nature (London, United Kingdom) (1951), 168, 827-8. Mayer-Gross et al. discloses the instant claimed compound, which from the STN search is
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Mayer-Gross et al.
5. Claims 1-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cornforth et al., Lancet (1952), 262, 950-2. Cornforth et al. discloses the instant claimed compound, which from the STN search is
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Cornforth et al.
6. Claims 1-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cerletti et al., Journal of Pharmacology and Experimental Therapeutics (1958), 122, 124-36. Cerletti et al. discloses the instant claimed compound, which from the STN search is
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,
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Cerletti et al.
7. Claims 1-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woolley et al., Annals of the New York Academy of Sciences (1957), 66, 649-67. Woolley et al. discloses the instant claimed compound, which from the STN search is
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,
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Woolley et al.
8. Claims 1-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caspar et al., Talanta (2018), 176, 635-645. Caspar et al. discloses the instant claimed compound, which from the STN search is
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Caspar et al.
9. Claims 1-56 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Beyer et al., WO 2015162251. Caspar Beyer et al. discloses the instant claimed compound, which from the STN search is
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Beyer et al.
10. Claims 1-56 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nichols et al., US 9642819. Nichols et al. discloses the instant claimed compound, which from the STN search is
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, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Nichols et al.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/
06/04/2025
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