DETAILED ACTION
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 amendment, filed 07/17/2023, has been entered.
Claims 1-26 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/05/2025 is acknowledged.
Claims 8-14, 23-26 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions, there being no allowable generic or linking claim.
Claims 1-7 and 15-22 are currently under examination as they read on a method of expanding tumor-infiltrating lymphocytes (TILs) expressing membrane-bound IL15 (mbIL15) comprising culturing the TIL in the presence of modified K562.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "the modified T cells or TILs". There is insufficient antecedent basis for this limitation in the claim. Therefore, the claim and dependent claims thereof are indefinite. For the purposes of examination under prior art, “the modified T cells or TIL.” read on any T cells or TILs.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 15, 17, 18, 20, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hurton et al. (PNAS 2016 113 (48) E7788-E7797).
Hurton et al. disclosed a method of expanding CAR T cells engineered to express membrane-bound IL15 comprising culturing the CAR T cells in the presence of modified K562 cells (see E7789, right column, Results). The prior art method does not include addition of exogenous IL2. The modified K562 were gamma-irradiated, rendering them replication incompetent, and expressed CD137L (aka 4-1BBL) (see SI Appendix, Materials and Methods, page 5, second paragraph).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6, 7, 16, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hurton et al. (PNAS 2016 113 (48) E7788-E7797) in view of Denman et al. (PLoS ONE 2012 7(1) e30254).
The teachings of Hurton et al. have been discussed above (see 102).
The difference between Hurton and the present claims is the K562 feeder cells expressing Il21 or IL7, specifically membrane-bound IL21. However, it would have been obvious for one of ordinary skill in the art to use modified K562 cells expressing mbIL21 in view of Denman et al. In particular, Denman was cited by Hurton with regards to K562 clone 9 (SI Appendix, Materials and Methods, page 5, first paragraph). Denman taught that clone 9 was derived from K562 expressing 4-1BBL and that another clone named clone 9.mbIL21 was derived from clone 9 being transduced with another exogenous nucleic acid sequence to express mbIL21 (page 2, Cells and cell lines, Table 1). Moreover, clone 9.mbIL21 was shown to support NK cell log-phase expansion without evidence of senescence for up to 6 weeks of culture making it ideal for clinical use in propagating NK cells for adoptive immunotherapy (see Results). Therefore, one of ordinary skill in the art would have been motivated to use clone9.mbIL21 for expanding TILs as disclosed in Hurton et al.
The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements (using a modified K562 feeder cells to expand mbIL15-expressing TILs; mbIL21-expressing K562 feeder cells exhibiting enhanced ability to expand TILs) were known in the prior art and one of skilled in the art would have arrived at the claimed invention by using known methods with no change in their respective function and the combination would have yielded nothing more than the predictable result of using mbIL21-expressing K562 feeder cells to expand mbIL15-expressing TILs.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hurton et al. (PNAS 2016 113 (48) E7788-E7797) in view of Elpek et al. (US Patent 11,058,725 B2).
The teachings of Hurton et al. have been discussed above (see 102).
Hurton did not teach mbIL15 operably linked to a drug responsive domain (DRD). However, it would have been obvious to make a DRD linked to IL15 as it was well-known in the art before the effective filing date of the claimed invention. For example, Elpek et al. disclosed a mbIL15 operably linked to a DRD that is derived from human carbonic anhydrase II and TILs engineered to express said mbIL15 linked to the DRD (see, e.g., Claims).
The rationale to support a conclusion that the claims would have been obvious is that all the claimed elements (mbIL15-expressing TILs; TILs expressing mbIL15 operably linked to a DRD) were known in the prior art and one of skilled in the art would have arrived at the claimed invention by using known methods with no change in their respective function and the combination would have yielded nothing more than the predictable result of making expand TILs expressing mbIL15/DRD.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,058,725 and claims 1-15 of U. S. Patent No. 12,642,792 in view of Hurton et al. (PNAS 2016 113 (48) E7788-E7797) and Denman et al. (PLoS ONE 2012 7(1) e30254).
The patent claims disclosed engineered TIL expressing mbIL15 operably linked to DRD. As such, it would have been obvious to use the methods disclosed by Hurton and Denman to use modified K562 feeders cells expressing mbIL21 to expand the population of engineered TIL disclosed by the patent claims for reasons stated above (see 102 and 103). Therefore, the patent claims would render obvious of the present claims in view of Hurton and Denman.
Claims 1-7, 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17-20 of copending Application No. 18723120 in view of Hurton et al. (PNAS 2016 113 (48) E7788-E7797) and Denman et al. (PLoS ONE 2012 7(1) e30254).
The claims of the copending application disclosed TILs modified to express mbIL15and expanding the modified TIL with K562 feeder cells expressing 41BBL and IL21. As such, it would have been obvious to use the methods disclosed by Hurton and Denman to use modified K562 feeders cells expressing mbIL21 to expand the population of modified TIL disclosed by the copending claims for reasons stated above (see 102 and 103). Therefore, the reference claims would render obvious of the present claims in view of Hurton and Denman.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-37 of copending Application No. 18261765 in view of Hurton et al. (PNAS 2016 113 (48) E7788-E7797) and Denman et al. (PLoS ONE 2012 7(1) e30254).
The claims of the copending application disclosed TILs engineered to express mbIL15and expanding the TIL with K562 feeder cells and 41BBL and IL-21. As such, it would have been obvious to use the methods disclosed by Hurton and Denman to use modified K562 feeders cells expressing mbIL21 to expand the population of modified TIL disclosed by the copending claims for reasons stated above (see 102 and 103). Therefore, the reference claims would render obvious of the present claims in view of Hurton and Denman.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 15-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-5, 7-16 of copending Application No. 18501621 in view of Hurton et al. (PNAS 2016 113 (48) E7788-E7797) and Denman et al. (PLoS ONE 2012 7(1) e30254).
The claims of the copending application disclosed TILs engineered to express mbIL15 operably linked to a DRD and expanding the TIL with K562 feeder cells expressing 41BBL and mbIL-21. As such, it would have been obvious to use the methods disclosed by Hurton and Denman to use modified K562 feeders cells expressing mbIL21 to expand the population of modified TIL disclosed by the copending claims for reasons stated above (see 102 and 103). Therefore, the reference claims would render obvious of the present claims in view of Hurton and Denman.
This is a provisional nonstatutory double patenting rejection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON X WEN whose telephone number is (571)270-3064. The examiner can normally be reached Mon-Fri 8-5.
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/SHARON X WEN/Primary Examiner, Art Unit 1641
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