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 .
Applicants’ amendments and remarks filed September 11, 2026 have been received and reviewed. Claims 1, 12-16 and 20-23 are pending in this application.
Claim Rejections - 35 USC § 112
Claims 1, 12-16 and 20-23 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 treating CML and neuroblastoma, does not reasonably provide enablement for treating hematopoietic malignancies and solid tumors generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The basis of this rejection is the same as given in the previous office actions and is incorporated herein fully by reference. Applicants’ arguments and declaration have been fully considered. The testing done supports the treatment of CML and neuroblastoma. However, this showing is not commensurate in scope with the breadth of the claims. No inhibitor of Abelson kinase 1 or Abelson kinase 2 has been established to treat any other cancer. Therefore, one skilled cannot say for sure which hematopoietic malignancies or solid tumors are treatable by inhibiting Abelson kinase 1 or Abelson kinase 2.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221', Ex parte Jovanovics, 211 USPQ 907., MPEP 2164.05(a).
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 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 BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 22, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624