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 1-5 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.
Claims 1-5 are 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, while being enabled for the treatment of osteoporosis by administering miltefosine, does not reasonably provide enablement for preventing. 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 osteoporosis by administering miltefosine.
(2) State of the Prior Art: The state of the art regarding treating osteoporosis is relatively high, however the state of the art for the prevention of osteoporosis 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 osteoporosis by administering miltefosine.
(4) Guidance of the Specification: The guidance of the specification as to the prevention of osteoporosis is completely lacking. The specification discloses preventing the onset of osteoporosis. However, the specification fails to mention how one is able to determine whether the onset of osteoporosis 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 osteoporosis 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 osteoporosis. The specification does not disclose how one of ordinary skill in the art at the time of the invention would be able to prevent osteoporosis, nor does the prior art reveal any type of prevention associated with osteoporosis.
(6) The Relative Skill of those in the Art: One of ordinary skill in the art does not know how to prevent osteoporosis. Moreover, one is unable to determine whether a subject will ever develop a osteoporosis should this subject be administered miltefosine.
(7) Working Examples: The specification does not give any data for the prevention of osteoporosis by administering miltefosine.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the prevention of osteoporosis. 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.”
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter, which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The claims provide for the use of the claimed invention, but since the claim(s) does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Specifically, claim 1 recites “an application method” followed by “promoting bone formation and preventing and treating osteoporosis.” Therefore, it is not clear whether the claims should be interpreted as a method of application or a method of promoting bone formation or a method of treating/preventing osteoporosis. Finally, the claim does not specify administration of miltefosine to an actual subject, therefore the patient population is not defined.
Claims 1-5 are also rejected under 35 U.S.C. 101, because the claimed recitation of a use without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd. V. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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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