DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. The restriction requirement dated February 24, 2026 is withdrawn.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
4. The information disclosure statements (dated January 18, 2024 and November 3, 2025 and March 6, 2026) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
5. Claims 13 and 14 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being treating cancer, does not reasonably provide enablement for preventing cancer or treating the other disorders within the scope of the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242
ITS, 261,270 (1918) which postured the question: is the experimentation needed to
practice the invention undue or unreasonable? That standard is still the one to be
applied, at re Wands, 858 F.2d 731, 737, 8USPQ2s 1400, 1404 (Fed. Cir. 1988). MPEP 2184. 01(a) slates “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.” The factors are applied below to the instant claims.
The breadth of the claims and nature of invention
The claims are drawn to methods of treating and preventing cancer. The claims are also drawn to methods of treating and preventing a wide scope of diseases which include, for example, neurodegenerative disorders such as Alzheimer’s disease.
The state of the prior art, level of ordinary skill, level of predictability, amount of guidance provided
The state of the art and present specification recognizes that cancer can be treated using agents of the present utility. However, neither the state of the art nor the present specification recognizes that cancer can be prevented. See for example reference of Cancer Prevention. In the state of the art, cancer is not known to be preventable. Reducing the risk involves lifestyle choices, and not the administration of pharmaceutical agents.
The state of the art does not recognize the treatment of disorders other than cancer using agents of the present utility. See for example reference of Wang et al. which delineates the state of the art in treating by PLK1 modulation. Furthermore, the state of the art does not recognize that diseases other than cancer are preventable. See for example reference of AD-prevention.
The quantity of experimentation needed to make or use the invention
In the absence of working examples/direction, enablement rests on the existence of an
art recognized predictable correlation between the disclosed activity and the claimed
method. Evidence suggests that this requirement is not met for the instant case. The
amount of experimentation is undue. The experimentation required is to find a method for preventing cancer using animal and other models. Furthermore, the experimentation will have to indicate that cancer is prevented. The experimentation required is also to find methods of treating and preventing the full scope of diseases claimed using the present utility and claimed compounds. It is therefore determined that the instant disclosure does not enable one of ordinary skill to practice the scope of the claimed invention.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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