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 .
Receipt and entry of the response dated 7/16/2026 is acknowledged.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5, 10-12, 14, 15, 17-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Metelitsa et al (WO2013/040371, of record, and the corresponding PGPUB US 20140255363 A1) in view of Hanai et al (WO 01/23573, of record) and Nakamura et al (Cancer Immunol., 2001, of record).
Claim(s) 1, 3, 5, 10-12, 14, 15, 17-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Metelitsa et al (WO2013/040371, of record, and the corresponding PGPUB US 20140255363 A1) in view of Hanai et al (WO 01/23573, of record), Nakamura et al (Cancer Immunol., 2001, of record) and Tur et al (2001, of record).
These rejections are maintained for reasons made of record in the Office Action dated 1/16/2026 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 7/16/2026 have been fully considered but they are not persuasive. Applicants essentially assert that the instantly claimed huKM666 CAR provides unexpected, superior results to that of Metelitsa et al.
Such is not convincing because the combination of the references provides the same huKM666 CAR as instantly claimed. The teachings of Nakamura and Hanai et al teach GD2 binding specificity by the huKM666 sequences, thus it is not surprising that a huKM666 CAR provides GD2-specific CAR T cell activity.
Claim Rejections - 35 USC § 112
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 1, 3-15, 17-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is maintained for reasons made of record in the Office Action dated 1/16/2026 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 7/16/2026 have been fully considered but they are not persuasive. Applicants essentially assert that the instant claims require the VH and VL of SEQ ID NO:10 and SEQ ID NO:12. Such is not convincing. Due to claim language reciting that the VH and VL domains comprise specific CDRs in claim 1 (which should be redundant if the same CDRs are found within SEQ ID NOs 10 and 12) and independent claims that recite significantly broader VH and VL sequences (e.g. claims 3 and 13), the claims are not interpreted in such a limited manner as applicants assert.
Double Patenting
Terminal Disclaimer
The terminal disclaimer filed on 7/16/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,879,016 and US 10,975,162 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 16 is 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 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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/ Primary Examiner, Art Unit 1638
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