DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 The election of species requirement is withdrawn. The full scope of the claims was searched and examined.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1, 10-12, 15-19, 23, 24, 39, 42, 56, 62, 83, 90-92 and 121 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 treatment, does not reasonably provide enablement for prevention. 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 various diseases.
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 the treatment of diseases using the utility of the claimed compounds. However, neither the state of the art nor the present specification recognizes that the diseases can be prevented by the administration of pharmaceuticals. The prevention of stroke includes lowering risk factors such as smoking, obesity, heart disease etc. “Researchers at NINDS predict that, with continued attention to reducing risks of stroke and by using currently available therapies and developing new ones, Americans should be able to prevent 80 percent of all strokes.” Regarding other disease(s) in the scope of the claims, the state of the art discloses “within the context of this study, this meant that the three areas showed promise, but more results from clinical trials would be needed to determine whether these interventions could help prevent these conditions.” “While nothing has been proven yet to prevent Alzheimer’s, researchers have identified promising strategies and are learning more about what might – and might not – work.” See for example references of AD-prevention and Stroke-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 the claimed diseases using animal and other models, and the results will have to indicate that prevention is effective. 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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