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 .
Applicant’s amendments, filed 6/15/2026, is acknowledged.
Claims 3, 11-15, 17, 19-87, 90-95, 97-100, 104-113, and 116-164 are cancelled.
Claims 1, 2, 4-10, 16, 18, 88, 89, 96, 101, 102, 103, 114, 115, and 165 are currently pending.
Claims 9, 102, and 103 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or Species.
Claims 1, 2, 4-8, 10, 16, 18, 88, 89, 96, 101, 114, 115, and 165 are under examination.
Claim 1 is an independent claim.
In view of the amendments and remarks filed on 12/04/2025, the following rejections remain.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-8, 10, 16, 18, 88, 89, 96, 101, 114, 115, and 165 stand as rejected under 35 U.S.C. 103 as being unpatentable over Picker et al. (U.S. PGPub 20180133321, in Office Action mailed 12/16/2025) in view of Schneck et al. (U.S. PGPub 20020127231, in Office Action mailed 12/16/2025), as evidenced by Santis et al. (Eur J Immunol. 1992 May;22(5):1253-9. doi: 10.1002/eji.1830220521, in Office Action mailed 12/16/2025).
The claims are rejected for the same reasons discussed in the Office Action mailed on 12/16/2025.
Applicants arguments, filed 6/15/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the currently claimed invention is unexpected over the prior art (Remarks pg. 10): “[t]he recognition of this aspect of CMV vector-delivered antigens was not previously known and was unexpected. As described in Example 1 of the present application, Rhesus macaques administered RhCMV-68-1/gag and then RhCMV-68-1/TB developed MHC-E restricted CD8+ T cells that recognized multiple SIVgag supertope peptides…”
However, it is the Examiner’s positions that: (i) this showing of unexpected results is not commensurate in scope with the invention as claimed. The claims are directed to methods of generating broad genera of multi-specific TCRs instead of the specific examples of generating MHC-E restricted T-cells that were found to bind to two different SIVgag peptide epitopes. There is no showing that other embodiments falling within the claims will behave in a similar unexpected manner. For example, there is no showing of methods of generating multispecific TCRs that bind to, for example, a MHC-E bound epitope as well as a MHC-Class 1 bound epitope (such as HLA-A).
(ii) The results of unexpected results must be due to the claimed features, not to unclaimed features. The instant claims do not recite methods of generating multispecific MHC-restricted T-cells that bind to different SIVgag supertope peptides, such as Gag211-222 and Gag290-301 (Example 1).
Applicant additionally argues that the reference of Picker et al. does not specifically teach methods of generating multispecific TCRs, and thus the combination of references constitutes improper hindsight (Remarks pg. 11).
However, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. In re McLaughlin , 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). See MPEP 2145.
Appellant’s assertion that it is only with improper hindsight that the Examiner can combine Picker et al. and Schneck et al., to arrive at the instant invention, is misplaced; as the combination of references takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from Applicant's disclosure; thus, such a reconstruction is proper.
Applicant further argues that Schneck et al. does not teach generation of multispecific TCRs using methods similar to the instant claimed method (Remarks pg. 11 and 12).
However, in response to applicant’s arguments against the references individually, one cannot show non-obviousness by attacking references individually where the rejections are based on combination of references. See MPEP 2145. Contrary to applicant’s arguments against the references individually, note that One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because "[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA]." In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012). See MPEP 2145 IV.
It is noted that in considering the disclosure of a reference, it is proper to take into account not only specific teaching of the reference but also the inferences which one skilled in the art would be reasonably be expected to draw therefrom In re Preda, 401 F.2d 825, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01.
Furthermore, specific statements in the references themselves which would spell out the claimed invention are not necessary to show obviousness, since questions of obviousness involves not only what references expressly teach, but what they would collectively suggest to one of ordinary skill in the art. See CTS Corp. v. Electro Materials Corp. of America 202 USPQ 22 (DC SNY ); and In re Burckel 201 USPQ 67 (CCPA). In re Burckel is cited in MPEP 716.02.
Here, given the teachings of Picker et al. in teaching a method of generating TCRs that meet the limitations of instant claim 1(a)-(e), and Schneck et al. teaching methods of selecting high-avidity multispecific TCRs (i.e., instant claim 1(f)-(g)), the ordinary artisan at the time the invention was made would have had a reasonable expectation of success of making a method of generating a multispecific TCR.
Applicant additionally argues that Picker et al. does not specifically teach methods of generating multispecific TCRs.
However, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Also see MPEP § 2144(IV).
In the instant case, in absence of evidence to the contrary, it is Examiner’s position that one with ordinary skill in the art would be able to use the teachings of Picker et al. to generate multispecific TCRs by administering multiple different CMV vectors. Applicant asserts that Picker et al. teaches such methods (Remarks pg. 12): “…the embodiments of Picker wherein multiple CMV vectors are administered…” While Picker et al. does not specifically teach administration of two different epitopes, one with ordinary skill in the art would be motivated to use two different epitopes to generate a multispecific TCR.
Additionally, Applicant asserts (Remarks pg. 12): “[i]n line with that approach, the antigen delivered by the “second CMV vector” may be iudentical to the antigen delivered by the “first CMV vector”…”.
This is found to be not convincing because: 1) the instant claims do not preclude administration of identical first and second CMV vectors; and 2) as stated supra, one with ordinary skill in the art would be able to use these teachings of Picker et al. to generate multispecific TCRs by administering multiple different CMV vectors.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, 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, 2, 4-8, 10, 16, 18, 88, 89, 96, 101, 114, 115, and 165 stand as rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-67 of U.S. Patent No. 10,532,099 (Pat ‘099, in Office Action mailed 12/16/2025) in view of Schneck et al. (U.S. PGPub 20020127231, in Office Action mailed 12/16/2025, supra), as evidenced by Santis et al. (Eur J Immunol. 1992 May;22(5):1253-9. doi: 10.1002/eji.1830220521, in Office Action mailed 12/16/2025, supra). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims are rejected for the same reasons discussed in the Office Action mailed on 12/16/2025.
Applicants arguments, filed 6/15/2026, have been fully considered, but have been found to be not convincing. Applicant has argued that for the same reasons discussed for the 35 U.S.C. § 103 rejection supra, the nonstatutory double patenting rejection should be withdraw. However, this has been found to be not convincing for the reasons discussed supra.
Conclusion
No claim is allowed.
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 ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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