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 .
112(a) Rejections Withdrawn
The rejection of claim 151 under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, outlined in the previous Office Action, is withdrawn, in light of inventor’s amendment, and reformulated below.
Allowability Withdrawn
The allowability of claim 152 is withdrawn in order to include this claim in the reformulated 112(a) rejection below.
Claim Rejections - 35 USC § 112(a), NEW
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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 151 and 152 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 a method of treating a disease, disorder of condition characterized by increased RUNX1 function by applying or administering the composition of claim 93, does not reasonably provide enablement for a method of preventing such a disease, disorder or condition. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (MPEP 2164.01(a)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure.
a)The claims are extraordinary broad: “A method of treating or preventing a disease, disorder or condition associated with or caused by an overexpressed and/or overreactive RUNX transcription factor, wherein the method comprises applying or administering to a subject in need thereof an effective amount of the pharmaceutical composition of claim 93” (claim 151). Dependent claim 152 further defines the disease, disorder or condition as an ocular disease, disorder or condition.
b,c) The nature of the invention is determined in part by the state of the prior art.
As evidenced by, for instance, Journal of Biomedicine and Biotechnology (2012), Article ID 456534, 7 pages, it has been known in the medical arts for some time that overexpression of a RUNX transcription factor (RUNX2) is associated with advanced tumor progression and poor prognosis in epithelial ovarian cancer (abstract).
And as even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where any and all diseases, disorders or conditions associated with RUNX overexpression or overactivity – which would include disease with a significant genetic component such as cancers, as evidenced by Journal of Biomedicine and Biotechnology cited above – including any and all ocular diseases, disorders or conditions, can be said to be prevented.
d) The level of skill in the art is considered to be relatively high.
e) The level of predictability in the art is considered to be relatively low.
The basis of all modern medicine and biology is, of course, chemistry. Yet even under the best of circumstances, and more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. Neither the medicinal/biological arts nor the chemical arts upon which they are based have advanced to the point where certainty has replaced the need for clinical and/or laboratory experimentation.
Cancer, for instance, is neither a simple disease, nor a single disease. While some cancers can be treated in some hosts using specific compounds, the effective treatment - let alone prevention - of various forms of cancer remains highly unpredictable in the art.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. All of inventor’s working examples are drawn to investigations with respect to proliferative vitreoretinopathy. Inventor’s working examples do not demonstrate that applying or administering the instant composition of claim 93 is efficacious in the prevention of any and all diseases, disorders and conditions associated with an overexpressed and/or overactive RUNX transcription factor.
h) It would clearly require an absolutely extraordinary – and thus undue – amount of experimentation (clinical trials, etc.) in order to determine if, in fact, extrapolation from inventor’s limited working examples, all with respect to the treatment of proliferative vitreoretinopathy, is at all reasonable with respect to the prevention of any and all diseases, disorders or conditions associated with an overexpressed and/or overactive RUNX transcription factor.
112(b) Rejections Withdrawn
The rejections of claims 26 and 87 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, have been overcome by inventor’s amendment. The amendment clarifies the claims as appropriate.
Allowable Subject Matter
Claims 1, 2, 14-16, 24, 26, 28, 35, 40, 43, 74, 76, 87, 93, 137 and 172 are allowed for reasons of record (3/2/2026).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 9/15/2026
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