DETAILED ACTION
Claims 1-27 are pending in the instant application.
2. 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.
Claim 26 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 26 is rejected because the term “claim 1” is confusing. Does claim 26 depend to claim 25? Correction is required.
3. 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 23, 25-27 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibition of GLP-1, does not reasonably provide enablement for treating GLP-1 associated disease. 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 GLP-1 associated 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 GPL-1 inhibitors and treating GLP-1 associated disease. There is no guidance in the prior art that GPL-1 inhibitor could be useful to treat GLP-1 associated disease.
The predictability in the art: At present using GPL-1 to treat GLP-1 associated disease 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 GPL-1 on page 84. However, there is no guidance for using a therapeutically effective amount of a compound of Formula (I) to treat GLP-1 associated disease.
The breadth of the claims: The claims encompass a method for treating GLP-1 associated disease.
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 23, 25-27, for treating diseases associated with therapeutically effective amount of a compound of Formula (I) is efficacious, have been enabled by the instant specification.
4. Allowable Subject Matter
Claims 1-22 are patentable over Meng et al., US 11492365, which includes the exemplified compound:
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576
790
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, which has
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96
108
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instead of
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74
84
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in the instant claims. Therefore, the claims are free of prior art.
5. Claim Objections
Claim 24 is objected to as being dependent upon a rejected base claim 23, but would be allowable if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
6. 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/
06/18/2026
Prosecution Insights