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 9/17/26. Claims 2-3, 5-9, 11-16, 18, 20-21, 23-27 have been cancelled. Claims 28-31 have been added. Claims 1, 4, 10, 17, 19, 22, 28-31 are pending. Claims 1, 10, 17, 19 have been amended. Claims 1, 4, 10, 17, 19, 22, 28-31 are examined herein.
The claim amendments have rendered the claim objection and first 112 rejection of the last Office Action moot, therefore hereby withdrawn.
Applicant’s arguments with respect to the second 112 rejection have been fully considered but found not persuasive, therefore maintained for reasons of record and modified below due to the claim amendments.
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, 4, 19, 22, 28-31 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.”
Response to Arguments
Applicant argues that the therapeutic effects of other PI4KIIIα specific inhibitors can be reasonably expected from the experimental results in the specification (Examples 1-7, Figures 1-4, 7, 12, 15). Taken together, these results demonstrate that the therapeutic effect is reproduced not only by structurally distinct small molecule inhibitors, but also by genetic knockdown of PI4KIIIα via shRNA. Therefore, it is the mechanism of “inhibition of PI4KIIIα”, rather than the structural features of a particular compound that drives the therapeutic effect. Moreover, in Applicant’s granted patent (US 11,766,420), the Office allowed a method for treating Alzheimer’s disease using a PI4KIIIα inhibitor.
This is not persuasive because the small number of compounds disclosed in Examples 1-7, Figures 1-4, 7, 12, 15 of the specification cannot possibly support the large genus of any and all PI4KIIIα specific inhibitors as recited in claim 1. In fact, claim 4 recites that the claimed PI4KIIIα specific inhibitors can be an antibody, a small molecule compound, an RNAi molecule, or an antisense nucleic acid. Where is the support for these subgenuses that are not small molecules? Furthermore, Applicant is reminded that the claims are drawn to a method of treating the intracellular protein misfolding-related disease, Lewy body dementia. However, the data only shows a small genus of small molecules that inhibit PI4KIIIα. It remains to be seen if and how inhibition PI4KIIIα by these compounds can translate to actual treatment of Lewy body dementia. Lastly, the prosecution of another related application has no bearing on the instant application.
Claim Objections
Claims 10 and 17 are 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
THIS ACTION IS MADE FINAL. 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 mailing 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.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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