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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/9/26 has been entered.
Claim 1 is amended.
Claims 1, 7-15, 17 and 19-22 remain pending and are considered herein.
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, 7-15, 17 and 19-22 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.
The claims have been amended in the amendment of 6/9/26, to remove the presence of IL-2 and OKT3 from the second expansion, to produce the third population of TILs. All that is now required for the second expansion is the presence of APCs.
The specification only conceives of the second expansion as requiring both IL-2 and OKT3, in addition to the claimed APCs, to produce the third population of TILs, which is the therapeutic population. For example, paragraphs 9-10, 41-42, 51, 61-62, 83, 265-266, 287, 324, 326, 343 require the presence of IL-2 and OKT3. There not even contemplation, much less a demonstration of possession for the absence of IL-2 and OKT3 in this second expansion.
In addition, IL-2 and OKT3 are both known to affect T cell differentiation e.g., Hinrichs, et al. (2008) “IL-2 and IL-21 confer opposing differentiation programs to CD8+ T cells for adoptive immunotherapy”, Immunobiology, 111(11): 5326-5333, e.g., ABSTRACT and Popma, et al. (2005) “Anti-CD3 antibodies OKT3 and hOKT3γ1 (Ala-Ala) induce proliferation of T cells but impair expansion of alloreactive T cells; aspecific T cell proliferation induced by Anti-CD3 antibodies correlates with impaired expansion of alloreactive T cells”, International Immunopharmacology, 5: 155-62, demonstrate that these compounds affect the state of differentiation and proliferation, such that the Aritsan would not know if their absence would have affects on the cells that would preclude the obtained cells use.
Therefore, given the teachings in the art that the compounds influence T cell differentiation and behavior, and the absence of even contemplation by Applicant of the absence of OKT3 and IL-2 during this second expansion, the Artisan would not have understood Applicant to have been in possession of the claimed subject matter at the time of filing.
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.
Patents:
Method of Expanding TILs
In light of the acceptance of the termina disclaimer of 5/8/26, the rejections of the claims on the ground of nonstatutory double patenting as being unpatentable over the claims, each separately, of U.S. Patent Nos. 10,639,330; 10,918,666; 11,007,226; 11,040,070; 11,168,303; 11,168,304; 11,254,913; 11,273,180; 11,291,687; 11,304,979, 11,344,581; 11,529,372; 11,541,077; 12,024,718; 11,939,596; 12,280,140; 12,188,048 and 12,226,434, are withdrawn.
TILs
In light of the acceptance of the terminal disclaimer of 5/8/26, the rejections of the claims on the ground of nonstatutory double patenting as being unpatentable over the claims of each, separately, of U.S. Patent Nos. 10,398,734; 10,537,595; 10,695,372; 10,894,063; 11,052,115; 11,052,116; 11,337,998; 11,344,579; 12,031,157; 12,194,061; and 11,865,140, are withdrawn.
Method of Treating Cancer
In light of the acceptance of the terminal dislaimers of 5/8/26, the rejections of the claims on the ground of nonstatutory double patenting as being unpatentable over the claims, each separately, of U.S. Patent Nos. 10,130,659; 10,166,257; 10,272,113; 10,363,273; 10,463,697; 10,646,517; 10,653,723; 10,905,718; 10,925,900; 10,933,094; 10,946,044; 10,946,045; 10,953,046; 10,953,047; 11,007,225; 11,013,770; 11,083,752; 11,202,803; 11,202,804; 11,241,456; 11,273,181; 11,364,266; 11,517,592; 11,401,507; 12,121,541; and 11,998,568, are withdrawn.
Applications:
Method of Expanding TILs
In light of the acceptance of the terminal disclaimer of 5/8/26, the rejections of the claims on the ground of nonstatutory double patenting as being unpatentable over the claims, independently, of copending Application Nos. 17/147,412; 18/337,454; 18/668,092; 18/957,327; 18/957,327 and 18/984,595, are withdrawn. (reference application).
In light of the abandonment of Application No. 18/781,928, the rejections on the ground of nonstatutory double patenting as being unpatentable over the claims, against the same Application, is withdrawn.
Claims 1, 7-15, 17, and 19-22 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims, independently, of copending Application Nos. 17/997,648; 17/997,731; 18/262,365; 18/262,843; 18/291,536; 18/429,006; 18/551,138; 18/551,586; 18/555,513; 18/560,898; 18/609,772; 18/619,119; 18/661,510; 18/690,067; 18/693,508; 18/707,719; 18/832,901; 18/849,440; and 18/858,710. (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the references are drawn to methods of expanding TILs, but do not necessarily contain the same steps and structure. On the other hand, the essential written description for the subject matter claimed provides for the limitations such that the same subject matter is claimed. Thus, in light of the patents, the Artisan would make the invention, as it is claimed, and provided the same essential written description, and would expect success for the same reasoning. Further there is no restriction excluding the rejections.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Argument – NSDP rejections, pending Applications
Applicant’s argument of 6/9/26 has been considered but is not persuasive.
Applicant argues the claims are not obvious variants, broadly averring the same, without particularity (p. 6) and they should be withdrawn as being to earlier filed Applications (p. 7).
Such is not persuasive. The claims are properly rejected as NSDP, requiring a terminal disclaimer. As far as being the earlier filed Application, they will not be withdrawn, unless no other issue exist, including all the rejections against the patents for NSDP, addressed above. Here, a new rejection is provided in the action.
TILs
In light of the acceptance of the terminal disclaimer of 5/8/26, the rejections on the ground of nonstatutory double patenting as being unpatentable over the claims, independently, of copending Application Nos. 17/817,226*; 17/817,239*; 17/817,247*; 17/817,273*; 17/823,419*; 17/823,448*; and 17/856,806*, are withdrawn.
Claims 1, 7-15, 17, and 19-22 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims, independently, of copending Application Nos. 18/555,513; and 18/984,525. (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the references are drawn to TILs themselves, including product by process in instances, which requires, in the claims or as part of the essential written description for the claimed subject matter, providing the same steps. Thus, in light of each of the references, the invention is obvious. One would make the subject matter in process of making the TILs, and expect success, as it is claimed or provided as essential written description for the making of the TILs claimed. Further there is no restriction excluding the rejections.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Argument – NSDP rejections, pending Applications
Applicant’s argument of 6/9/26 has been considered but is not persuasive.
Applicant argues the claims are not obvious variants, broadly averring the same, without particularity (p. 6) and they should be withdrawn as being to earlier filed Applications (p. 7).
Such is not persuasive. The claims are properly rejected as NSDP, requiring a terminal disclaimer. As far as being the earlier filed Application, they will not be withdrawn, unless no other issue exist, including all the rejections against the patents for NSDP, addressed above. Here, a new rejection is provided in the action.
Method of Treating Cancer
In light of the acceptance of the terminal disclaimers of 5/8/26, the rejections on the ground of nonstatutory double patenting as being unpatentable over the claims, independently, of copending Application Nos. 16/969,362; 17/050,552; 17/110,179; 17/810,540; 17/817,217*; 17/817,276*; 17/823,454*; and 17/856,793*, are withdrawn. (reference application).
In light of the abandonment of 18/781,982, the provisional rejections on the ground of nonstatutory double patenting as being unpatentable over the same, are withdrawn.
Claims 1, 7-15, 17, and 19-22 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims, independently, of copending Application Nos. 18/247,877; 18/256,421; 18/256,798; 18/256,853; 18/291,536; 18/707,719; 18/745,958; 18/810,044; 18/832,901; 18/858,710; and 18/886,988. (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to treating cancers. However, the same either claims the same process of making the TILs, or claims the TILs in the use, of which the essential written description fills in those portions not directly claimed. Thus, the Artisan would have found the invention obvious in light of these patents. The Artisan would make the invention, in the process of treating the cancer. The Artisan would expect success, as it is claimed, or provided by way of essential written description for the claims. Further there is no restriction excluding the rejections.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Argument – NSDP rejections, pending Applications
Applicant’s argument of 2/12/26 has been considered but is not persuasive.
Applicant’s argument of 6/9/26 has been considered but is not persuasive.
Applicant argues the claims are not obvious variants, broadly averring the same, without particularity (p. 6) and they should be withdrawn as being to earlier filed Applications (p. 7).
Such is not persuasive. The claims are properly rejected as NSDP, requiring a terminal disclaimer. As far as being the earlier filed Application, they will not be withdrawn, unless no other issue exist, including all the rejections against the patents for NSDP, addressed above. Here, a new rejection is provided in the action.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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