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 The restriction requirement dated June 3, 2026 is withdrawn. The full scope of the claims was searched and examined.
Information Disclosure Statement
3. The information disclosure statements (dated June 3, 2026 and August 9, 2024) 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.
4. Claims 68, 70 and 71 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for amelioration of a disease, does not reasonably provide enablement for prevention of a 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 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 inflammatory diseases or cancer.
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 provides guidance for the treatment of inflammatory diseases or cancer. However, neither the state of the art nor the present specification recognizes that inflammatory diseases or cancer can be prevented by the administration of the agents of the present utility. In the state of the art the prevention of cancer or inflammatory diseases is not known to be preventable. A decrease in risk involves lifestyle choices, not the administration of medicines. See for example the references of Cancer-prevention and RA-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 and inflammatory diseases using animal and other models. Moreover, the results will have to indicate that the diseases within the scope of cancer and inflammatory diseases can be prevented using these models. 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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