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
This Office Action is in response to applicant’s arguments filed on 9/3/26. Claims 1-7, 11-13, 16, 20-22, 25, 29-31, 33 have been cancelled. Claims 8-10, 14-15, 17-19, 23-24, 26-28, 32, 34-37 are pending. Claims 8 and 26 have been amended. Claims 17-19, 23-24, 35, 37 have been withdrawn. Claims 8-10, 14-15, 26-28, 32, 34, 36 are examined herein.
Applicant’s arguments have been fully considered and found persuasive to withdraw all the rejections of the last Office Action. The following new rejection will now apply.
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 8-10, 14, 34 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant specification fails to provide information that would describe that the inventor had possession of the claimed invention and 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 a method of treating any and all motor disorders in a patient in need thereof by administering a compound 1 and compound 2.
(2) State of the Prior Art: The state of the art regarding a single compound or composition having the ability to treat any and all motor disorders 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 any and all motor disorders, ranging from Parkinson’s disease, tremors, dystonia, chorea & athetosis, tic disorders, developmental coordination disorder, or stereotypic movement disorder.
(4) Guidance of the Specification: The guidance of the specification is limited to the motor disorder, tremors.
(5) The Predictability or Unpredictability of the Art: The invention is directed to an unpredictable art because the various types of motor disorders have different symptoms, etiologies, and treatment regimens.
(6) The Relative Skill of those in the Art: One of ordinary skill in the art does not know how to treat any and all motor disorders by administering a single active agent or composition.
(7) Working Examples: The specification does not contain a working example of treating a motor disorder other than tremors.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the treatment of any and all motor disorders in a patient in need thereof by administering a compound 1 and compound 2. 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 Objections
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free).
/Yong S. Chong/Primary Examiner, Art Unit 1623
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