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 .
Status of the Application
Claims 1-13 are pending and are examined herein.
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.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not reasonably provide enablement for preventing or treating cancer or tumors in a subject in need thereof by administering a compound of formula I. The specification does not enable any person skilled in the art to which it pertains to practice the invention commensurate in scope with these claims.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547, the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the breadth of the claims; (4) the amount of direction or guidance presented; (5) the predictability or unpredictability of the art; (6) the relative skill of those in the art; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The Nature of the Invention: The rejected claims are drawn to an invention which pertains to a method of preventing and treating cancer or tumors in a subject in need thereof by administering a compound of formula I.
(2) State of the Prior Art: The state of the art regarding treating cancer or tumors is relatively high, however the state of the art for the prevention is non-existent.
(3) Breadth of Claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The claims encompass the prevention, inhibition, and treatment of any and all types of cancer and tumors.
(4) Guidance of the Specification: The guidance of the specification as to the prevention and treatment of cancer or tumors is completely lacking. The specification discloses preventing the onset of cancer or tumors. However, the specification fails to mention how one is able to determine whether the onset of cancer or tumors in a subject would have occurred in the absence of treatment, thus being unable to confirm that prevention has indeed taken place. Moreover, the specification fails to mention the complete prevention or cessation of cancer or tumors once the onset of preclinically evident stage is determined.
(5) The Predictability or Unpredictability of the Art: The invention is directed to a method of treating, inhibiting, and preventing any and all types of cancers or tumors. The specification does not disclose how one of ordinary skill in the art at the time of the invention would be able to prevent cancer or tumors, nor does the prior art reveal any type of prevention associated with the compounds of formula I.
(6) The Relative Skill of those in the Art: One of ordinary skill in the art does not know how to prevent cancer or tumors. Moreover, one is unable to determine whether a subject will ever develop a cancer or tumors should this subject be administered the compound of formula I.
(7) Working Examples: The specification does not give any data for the prevention or treatment of cancer or tumors by administering a compound of formula I.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the prevention or treatment of cancer or tumors by administering a compound of formula I. Nor does it provide information to practice the claimed invention, absent undue experimentation. Genetech, 108 F. 3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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