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 .
The text of Title 35 of the U.S. Code not reiterated herein can be found in the previous office action.
RESPONSE TO AMENDMENT
The amendment filed 4-10-2026 has been entered into the record. Claims 15, 18-20 and 22-26 are pending and under examination.
The substitute specification filed 4-10-2026 has been entered into the record.
Information Disclosure Statement
The information disclosure statement filed 4-10-2026 has been considered. An initialed copy is enclosed.
Objections/Rejections Withdrawn
The sequence requirement has been withdrawn in view of the properly filed substitute specification that resolves the noted issue.
Rejections Maintained
Claims 15, 18-20 and 22-26 stand 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 for reasons set forth for claims 15-26 in the Office action mailed 1-12-2026.
Applicant’s arguments have been carefully considered but are not persuasive. Applicant argues that since the amendment removes “treating a subject having cancer” from the preamble of the claim, the administration step is fully enabled. It is noted that the administration step has been amended to include that the administering is to a subject having differentiated thyroid cancer. The claims are read in-light-of the specification. By divorcing the disclosed uses from the administration step and the patient population, Applicant apparently argues that administration of the immune CAR cell does not have to meet the most basic tenant of 112(a) as teaching how to use the immune CAR cell as claimed. The administration of the anti-TSHR immune cell CAR is disclosed in the specification as providing for cell killing to provide for an anti-tumor effect or cell killing providing for treatment of the tumor/cancer (see specification paragraph bridging pages 3-4 and page 8, lines 8-12). The claims have been considered given all the disclosed administration uses provided for in the specification. The specification provides for no apparent use for administration other than those relied upon above. Thus, considering all the uses disclosed for the administration process to subjects having differentiated thyroid cancer, the claims remain non-enabled for any of those uses for reasons set forth in the Office Action mailed 1-12-2026. Therefore, removal of the “treating” as set forth in the preamble, does not enable the remaining disclosed uses of administration of the claimed immune cell CAR in the specification. The removal of therapeutic does not abrogate the rejection as it applies to the other disclosed use such as an anti-tumor effect by means of cell killing The claimed method must be enabled for a single disclosed use of administration of the recited CAR. As such, Applicant’s arguments are not persuasive.
Status of Claims
All claims stand rejected.
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 Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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