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 .
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) 144-152, 155-173 is/are rejected under 35 U.S.C. 103 as being unpatentable over June et al (US 6,534,055, of record) in view of Stadler (WO2013/124474, 8/29/2013, published as US 2015/0024411 A1) and Schmidt et al (WO 2013/011011, 1/24/2013, of record, published as US 2014/0295458 A1). This rejection is maintained for reasons made of record in the Office Action dated 4/28/2026 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) June et al do not teach positive selection of T cells by immobilization of the cells, rather that and that the cells are first purified via FACS, then stimulated in a separate vessel; 2) Stadler et al does not provide a teaching of stimulation of T cells, and uses temperatures lower than those of June et al; 3) Schmidt et al teaches certain temperatures that might avoid activation of T cells; 4) no rational reason to combine the references has been provided and June et al teaches away from modifications of their methods
Regarding 1), immobilization of T cells by activation or stimulation agents is taught by June et al in, e.g., col. 7, lines 6-60 and Example 4. Further, June et al teach the T cells are purified by a selection agent that specifically binds to a selection marker expressed by the target T cells such as CD8 or CD4 (col 4, col 8, col 20, col 34, col 46, see Example 12, col 55, see Example 17, col 57-58, Examples 19-20), considered “positive” selection despite applicants protests. Nevertheless, a teaching of immobilization is primarily taught by Stadler and Schmidt et al.
Regarding 2) and 3), such is not convincing. Both June and Schmidt et al teach their inventions to comprise both purification and stimulation. Further, Schmidt et al teach the specific reagents also used by June et al (e.g. anti-CD3) and suggest the combination of the two (Abstract, Fig. 1c, ¶’s [0046],[0054]). Stadler teaches the invention to be a substitute for the FACS or MACS of June et al (cols. 2-3 of US 10,228,312). A reading of the passages of Stadler and Schmidt et al cited by applicants does not rule out the desired activation or temperatures sought by June and/or Schmidt et al. Rather, Stadler and Schmidt et al teach that an undesirable functional change can be avoided using the “common specific” receptor used for purification (e.g. CD4), not that the functional status of the cells is invention is never to be altered when desired. The teachings of Schmidt et al clearly are directed to stimulation (e.g. with anti-CD3) when such is desired.
Further regarding 1) to 4), in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding 4), all of the cited prior art references share a significant nexus and teach the predictable use of the cited reagents and methods. Further, all of the references seek to improve upon the relevant methods of T cell stimulation/activation and purification for use in therapeutic methods. Nothing in June et al indicates that coupling activation and co-stimulatory agents to the same solid support is the only way to accomplish stimulating and purifying T cells, rather such coupling is taught to be one of many preferred embodiments. A reading of Example 14 of June et al does not support applicants conclusions. The example indicates that different amounts of anti-CD3 and anti-CD28 reagents were titrated at the same time, not that a comparison was made as to the timing of activation/stimulation. Further in Example 14, June et al, citing to Fig. 18B, found the CD8+ T cells expanded by either method had the same phenotype.
Claim(s) 144-173 is/are rejected under 35 U.S.C. 103 as being unpatentable over June et al, Stadler and Schmidt et al as applied to claims 144-152 and 155-173 above, and further in view of Skerra et al (US 6,103,493, of record) and Korndorfer et al (Protein Sci, 2002, of record). This rejection is maintained for reasons made of record in the Office Action dated 4/28/2026 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive. Applicants essentially assert that the additional references do not cure the deficiencies of June, Stadler and Schmidt et al. These references are not deemed to be deficient, hence, the rejection stands.
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 144-173 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-66 of U.S. Patent No. 11,913,024. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘024 claims recite methods of stimulating T cells by chromatography, CD3 and CD28 stimulating agents, a crosslinked tetramer of a streptavidin mutein, and selection agents that anticipate the instant claims. This rejection is maintained for reasons made of record in the Office Action dated 4/28/2026 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive. Applicants essentially assert that the rejection does not perform the proper analysis. Such is not convincing. Reference was made to the relevant claim numbers and patent, and explained how the specific ‘024 claims anticipate the instant generic 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.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
