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 .
Applicant’s amendments and remarks filed August 3, 2026 have been received and reviewed. Claims 1-6, 11-12, 14, 16, 40, 45, 57, 61-66, 68-69, 71-75, 77-79 and 81 are still pending in this application.
Allowable Subject Matter
Claims 1-6, 11, 12, 14, 16, 40, 45, 57 and 61-66 are allowed.
Claim Rejections - 35 USC § 112
Claims 68, 69, 71-75, 77-79 and 81 are again 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 claims 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 use the invention.
The basis of this rejection is the same as given in the previous office action and is incorporated herein fully by reference. Applicants’ arguments have been fully considered but not found persuasive.
Regarding claims 68 and 69, Applicants have still not provided what is being treated by claims 68 and 69. One skilled in the art cannot say for sure whether a given disease or disorder is somehow mediated by KRAS or KRAS mediated associated with the activity of a KRAS protein harboring a G12D mutation or a G12V mutation.
As stated in the previous office action, treatment of an immunological or inflammatory disorder generally would be unprecedented feat.
Case law is clear on this point. In an unpredictable art, models may be used for enablement only if there is a well-established correlation between the assay and clinical efficacy. Applicants have not demonstrated nor have they alleged there is any correlation between the assays they disclose and clinical efficacy against any disease.
Regarding the treatment of cancers as claimed in claims 71 and 81, nor the classes of cancers in claims 72-74, generally, Applicants arguments have been fully considered but not found persuasive. The references provided do nor the experimental data provide for treating cancers generally.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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August 11, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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