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 .
Status of the Claims
Claims 73-85 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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U.S. Patent No. 9,745,368 (application 14/214,824)
Claim 73-78, and 80-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, and 23 of U.S. Patent No. 9,745,368 (referred to as -368) in view of Wang X, Rivière I, Clinical manufacturing of CAR T cells: foundation of a promising therapy Molecular Therapy - Oncolytics, 3.
Regarding claim 73, claim 1 of the -368 patent is directed an actKIR-CAR. The -368 patent does not explicitly claim that the KIR-CAR receptor is encoded by the claimed nucleic acid. However, it would have been prima facie obvious to the skilled artisan to encode the receptor claimed in the -368 patent into a cytotoxic cell in a nucleic acid. The skilled artisan would be motivated to do so, and have a reasonable expectation of successfully doing so, because encoding a CAR on a nucleic acid and introducing the nucleic acid into a T cell or NK cell is well known and routinely done in the prior art. (Wang X, Rivière I, Clinical manufacturing of CAR T cells: foundation of a promising therapy Molecular Therapy - Oncolytics, 3)
Regarding claim 74, claim 2 of the -368 patent is directed to a KIR with a transmembrane domain that can interact with the transmembrane domain of a DAP12 polypeptide.
Regarding claim 75, Claim 3 of the -368 patent is directed to an actKIR transmembrane that comprises a positively charged moiety.
Regarding claim 76, Claim 4 of the -368 patent recites the limitation that the cytoplasmic domain is a KIR-cytoplasmic domain.
Regarding claims 77 and 78, claim 23 of the -368 patent recites the limitation that the binding domain comprises an antibody that binds CD-19
Claim 80 is directed to a actKIR-CAR encoded by a nucleic acid, which is identical to the actKIR-CAR disclosed in the independent claim 1 of the -368 patent.
Regarding Claim 81 and 82, claim 1 of the -368 patent is directed to a cytotoxic cell encoding the actKIR-CAR.
Regarding claim 83, the -368 patent does not specifically claim a method for introducing a nucleic acid encoding the claimed receptor into a cytotoxic cell. However, it would have been prima facie obvious to the skilled artisan to introduce the nucleic acid that encodes the receptor claimed in the -368 patent into a cytotoxic cell to produce a cell expressing the claimed receptor. The skilled artisan would be motivated to do so, and have a reasonable expectation of successfully introducing the vector/receptor because engineered CAR-T cells are widely known in the art, as is the practice of introducing nucleotides encoding the desired receptors into them. (Sadelain, Michel et al. “The basic principles of chimeric antigen receptor design.” Cancer discovery vol. 3,4 (2013): 388-98. doi:10.1158/2159-8290.CD-12-0548)
Allowable Subject Matter
Claims 79, 84, and 85 are 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.
Other than the double patenting rejections, all claims appear allowable. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art appears to be Applicant’s own disclosure, Wang, which does not qualify as prior art. (Wang, E., et al. "Generation of Potent T-cell Immunotherapy for Cancer Using DAP12-Based, Multichain, Chimeric Immunoreceptors. Cancer Immunol. Res. 3, 815–826." 2015 (Provided in IDS of 7/3/2024).
Prior to applicants’ disclosure, there appears to be no mention of the KIR-CAR concept in the art. In fact, the Wang reference itself admits that the authors effectively designed the KIR-CAR for the first time in their paper, and after a search of the prior art the examiner agrees.
Conclusion
Claim 73-78, and 80-83 are rejected.
Claims 79, 84, and 85 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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/THOMAS R. AMICK/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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