DETAILED ACTION
Claims 1-21 are pending in the instant application.
Applicant's election without traverse of group (II), claims 1-3, 5-18, where in W is -CH=CH- in the reply filed on 07/13/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19-21 are rejoined to claims 1-3, 5-18, wherein W is -CH=CH-. Claims 1-3, 5-21 in part wherein W is -CH=CH- are examined. Claim
4 and the remaining subject matter of claims 1-3, 5-21 are withdrawn per 37 CFR 1.142(b).
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 19-21 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibition of (SMSMs), does not reasonably provide enablement for treating diseases. 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 a disease, said method comprising administration of the compound or pharmaceutically acceptable salt thereof according to claim 1.
The state of the prior art: As indicated by the prior art, there is not any association between SMSMs inhibitors and treating diseases. There is no guidance in the prior art that SMSMs inhibitor could be useful to treat diseases.
The predictability in the art: At present using SMSMs to treat diseases 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 SMSMs on pages 256-263. However, there is no guidance for using a therapeutically effective amount of a compound of Formula (I) to treat diseases.
The breadth of the claims: The claims encompass a method for treating diseases.
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 19-21, for treating diseases associated with therapeutically effective amount of a compound of Formula (I) is efficacious, have been enabled by the instant specification.
4. Closest Art
Closest Art is US 4528371, which includes the exemplified compound:
PNG
media_image1.png
178
606
media_image1.png
Greyscale
, which has =O instant of
PNG
media_image2.png
52
78
media_image2.png
Greyscale
in the instant claims. Therefore, the claims are free of prior art.
5. 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.
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).
/NILOOFAR RAHMANI/
07/22/2026
Prosecution Insights