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
Applicant's election without traverse of Group II, drawn to a method of preventing or treating an intracellular protein misfolding-related disease by administering a PI4KIIIα specific inhibitor, and the species (phenylarsine oxide and Lewy body dementia), in the reply filed 4/10/26 is acknowledged.
Claims 1-4, 10-15, 17, 19-20, 22 are pending. Claims 2 and 20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1, 3-4, 10-15, 17, 19, 22 are examined herein insofar as they read on the elected invention and species.
Claim Objections
Claim 17 is objected to because of the following informalities: Two structures in the claim have no bond between the As and O atoms. Appropriate correction is required.
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, 3-4, 10-15, 17, 19, 22 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 the intracellular protein misfolding-related disease, Lewy body dementia, by administering the PI4KIIIα specific inhibitor, phenylarsine oxide of formula I, 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 Lewy body dementia by administering a phenylarsine oxide of formula I.
(2) State of the Prior Art: The state of the art regarding treating Lewy body dementia is relatively high, however the state of the art for the prevention of Lewy body dementia 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 Lewy body dementia by administering a PI4KIIIα specific inhibitor.
(4) Guidance of the Specification: The guidance of the specification as to the prevention of Lewy body dementia is completely lacking. The specification discloses preventing the onset of Lewy body dementia. However, the specification fails to mention how one is able to determine whether the onset of Lewy body dementia 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 Lewy body dementia 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 Lewy body dementia. The specification does not disclose how one of ordinary skill in the art at the time of the invention would be able to prevent Lewy body dementia, nor does the prior art reveal any type of prevention associated with Lewy body dementia.
(6) The Relative Skill of those in the Art: One of ordinary skill in the art does not know how to prevent Lewy body dementia. Moreover, one is unable to determine whether a subject will ever develop a Lewy body dementia should this subject be administered the PI4KIIIα specific inhibitor.
(7) Working Examples: The specification does not give any data for the prevention of Lewy body dementia.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the prevention of Lewy body dementia. 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 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, 3-4, 19, 22 are 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 the intracellular protein misfolding-related disease, Lewy body dementia, by administering the PI4KIIIα specific inhibitor, phenylarsine oxide compounds of formula I, does not reasonably provide enablement for any and all PI4KIIIα specific inhibitors. 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 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 Lewy body dementia by administering any and all PI4KIIIα specific inhibitors.
(2) State of the Prior Art: The state of the art regarding PI4KIIIα specific inhibitors is mainly focused on phenylarsine oxide compounds of formula I.
(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 any and all PI4KIIIα specific inhibitors.
(4) Guidance of the Specification: The guidance of the specification as to the PI4KIIIα specific inhibitors are limited to phenylarsine oxide compounds of formula I.
(7) Working Examples: The specification as to the PI4KIIIα specific inhibitors is limited to phenylarsine oxide compounds of formula I.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the method of preventing and treating Lewy body dementia by administering any and all PI4KIIIα specific inhibitors. 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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