DETAILED ACTION
Claims 1-6, 8-9, 12, 14, 16-17, 20, 22-23, 31-33, 35, 38-39, 42-44, 46, 49, 51, 53-57, 60-61, 67 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 38-39, 42-44, 46, 49, 51, 53-57, 60-61 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibition of KRAS and treating colorectal cancer, pancreatic cancer, lung cancer, thyroid cancer, breast cancer, esophageal cancer, cervical cancer, skin cancer, gastric cancer, bladder cancer head and neck cancer, does not reasonably provide enablement for treating diseases other than colorectal cancer, pancreatic cancer, lung cancer, thyroid cancer, breast cancer, esophageal cancer, cervical cancer, skin cancer, gastric cancer, bladder cancer head and neck cancer. 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 or disease associated with activity of KRAS, 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 KRAS inhibitors and treating a disease or disease associated with activity of KRAS other than colorectal cancer, pancreatic cancer, lung cancer, thyroid cancer, breast cancer, esophageal cancer, cervical cancer, skin cancer, gastric cancer, bladder cancer head and neck cancer. There is no guidance in the prior art that KRAS inhibitor could be useful to treat a disease or disease associated with activity of KRAS other than colorectal cancer, pancreatic cancer, lung cancer, thyroid cancer, breast cancer, esophageal cancer, cervical cancer, skin cancer, gastric cancer, bladder cancer head and neck cancer.
The predictability in the art: At present using KRAS to a disease or disease associated with activity of KRAS other than colorectal cancer, pancreatic cancer, lung cancer, thyroid cancer, breast cancer, esophageal cancer, cervical cancer, skin cancer, gastric cancer, bladder cancer head and neck cancer 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 KRAS on pages 234-237. However, there is no guidance for using a therapeutically effective amount of a compound of Formula (I) to treat a disease or disease associated with activity of KRAS other than colorectal cancer, pancreatic cancer, lung cancer, thyroid cancer, breast cancer, esophageal cancer, cervical cancer, skin cancer, gastric cancer, bladder cancer head and neck cancer.
The breadth of the claims: The claims encompass a method for treating a disease or disease associated with activity of KRAS.
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 38-39, 42-44, 46, 49, 51, 53-57, 60-61, 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 1-6, 8-9, 12, 14, 16-17, 20, 22-23, 31-33, 35, 67 are rejected under 35 U.S.C.1-2(a)(1) and 102(a)(2) as being anticipated by Atasoylu et al., US 20240368156. Atasoylu et al. discloses the instant claimed compound, which from the STN search is
PNG
media_image1.png
942
542
media_image1.png
Greyscale
,
PNG
media_image2.png
870
540
media_image2.png
Greyscale
, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Atasoylu et al.
4. Claims 1-6, 8-9, 12, 14, 16-17, 20, 22-23, 31-33, 35, 67 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Farren et al., US 20250114339. Farren et al. discloses the instant claimed compound, which from the STN search is
PNG
media_image3.png
310
480
media_image3.png
Greyscale
, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Farren et al.
5. Claims 1-6, 8-9, 12, 14, 16-17, 20, 22-23, 31-33, 35, 67 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Farren et al., US 20250114346. Farren et al. discloses the instant claimed compound, which from the STN search is
PNG
media_image3.png
310
480
media_image3.png
Greyscale
, which anticipates the instant compounds. Therefore, the instant claims are anticipated by Farren 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.
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/ Primary Examiner, Art Unit 1691 09/04/2026
Prosecution Insights