DETAILED ACTION
Claims 35-79 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 43, 67 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibition of (BTK) and treating leukemia, lymphoma, multiple myeloma, Waldenstrom’s macroglobulinemia, MS, arthritis, does not reasonably provide enablement for treating a (BTK)-associated cancer other than leukemia, lymphoma, multiple myeloma, Waldenstrom’s macroglobulinemia, MS, arthritis. 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 (BTK)-associated cancer, said method comprising administration of the compound or pharmaceutically acceptable salt thereof according to claims 35 or 59.
The state of the prior art: The state of the prior art: As indicated by the prior art, there is not any association between BTK inhibitors and treating (BTK)-associated cancer other than leukemia, lymphoma, multiple myeloma, Waldenstrom’s macroglobulinemia, MS, arthritis. There is no guidance in the prior art that BTK inhibitor could be useful to treat (BTK)-associated cancer other than leukemia, lymphoma, multiple myeloma, Waldenstrom’s macroglobulinemia, MS, arthritis.
The predictability in the art: At present using BTK to treat (BTK)-associated cancer other than leukemia, lymphoma, multiple myeloma, Waldenstrom’s macroglobulinemia, MS, arthritis 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 no examples of the test compounds to inhibit BTK. There is no guidance for using a therapeutically effective amount of a compound in claims 35 and 59 to treat (BTK)-associated cancer other than leukemia, lymphoma, multiple myeloma, Waldenstrom’s macroglobulinemia, MS, arthritis.
The breadth of the claims: The claims encompass a method for treating (BTK)-associated cancer.
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 43, 67, 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 § 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.
Claims 35-79 are 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.
Claims 35-79 are rejected because the structures in claims 35 and 59 are unclear. Is the structure in claims 35, 59 “a salt” or “co crystalline”? Correction is required.
4. 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 35-79 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Brandhuber et al., WO 2020/028258. Brandhuber et al. discloses the instant claimed crystalline form on pages 84-85 as follow:
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. The crystalline form of the above compound has similar XRPD peaks on pages 84-85, paragraph 316 and paragraph 602, pages 241-243. Therefore, the instant claims are anticipated by Brandhuber et al.
5. Claims 35, 59 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Guisot et al., WO 2017/103611. Guisot et al. discloses the instant claimed crystalline form on pages 33, and page 88, Example, 21 as follow:
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. Therefore, the instant claims are anticipated by Guisot et al.
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/
01/30/2026