DETAILED ACTION
This action is in reply to papers filed 5/14/2026. Claims 1-20 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220174921A1, Published 1/13/2022.
Withdrawn Rejections
The 103 (a) rejection of claims 19-20 as being rejected under 35 U.S.C. 112(b) is withdrawn in view of amendments made to claim 19.
Maintained Rejections
The nonstatutory double patenting rejection of instant claims over claims 1-22 of U.S. Patent No. 11259510 is maintained. Applicant’s arguments will be addressed following maintained rejection.
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 1-18 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11259510. The rejection is maintained for the reasons advanced in the previous office action and will not be reiterated herein.
Applicant’s arguments/Response to arguments
Applicant argues: Applicant respectfully submits that the present claims are directed to subject matter identified in the '073 OARR as Group IV (claims 1-17), Group V (claim 18) and Group X (claims 19-20), characterized by the Office as distinct inventions, which were subsequently cancelled throughout prosecution. Thus, Applicant submits that the present claims were "carved out of the [earlier filed] nonprovisional application ... as a result of a restriction requirement made by the examiner," as is proper for a divisional application.
Applicant further submits that, as the present application is properly designated as a
divisional application, as described supra, at pp. 14-16, the subject matter of the present claims is entitled to safe harbor under 35 U.S.C. § 121.
Accordingly, because the present application is properly designated as a divisional and because of the safe harbor protections under 35 U.S.C. § 121 provided by the same, Applicant respectfully submits that the OTDP rejection as set forth in the Office Action is inapplicable. As such, withdrawal of the same and allowance of the claims is respectfully requested.
In Response: Applicant’s arguments have been fully considered, but are not found persuasive. This is because the claims of the instant application are not consonant with the restriction requirement made by the examiner in the ‘073 Application and the claims have been changed in material respects from the claims at the time the requirement was made.
Groups IV, V and X were drawn to the following:
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146
596
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440
632
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The restriction, filed on 6/21/2019, was based on the claims filed 4/11/2018. Claims 102,103 and 109 representative of the groups above are copied below, in full.
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108
628
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For completion, claim 98 is copied below.
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196
668
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For completion, claim 71 is copied below.
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578
682
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778
680
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100
634
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426
704
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Instant claim 1, which Applicant indicates is directed to claim 102 is copied below.
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654
642
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Instant claim 18, which Applicant indicates is directed to claim 103 is copied below.
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114
652
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Instant claim 19, which Applicant indicates corresponds to claim 109 is copied below.
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662
686
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752
662
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In comparing instant claim 1 and claim 102 of the ‘073 Application, it is clear that consonant is not maintained. First, instant claim 1 narrows the non-human animal to a mouse. Further, the CD8 polypeptides of instant claim 1 require IgV-like domains which are not required by claim 102 of the ‘073 application. Note this analysis is similar for claim 18 of instant application. With respect to claim 19 of instant application, note that the objective of the claim is to use the composition to evaluate a humanized T cell immune response between mouse cells. Moreover, the claim requires a human or humanized β2 microglobulin. No such objection and/or element is required in claim 109 of the ‘073 Application.
Because Applicant’s arguments were not found persuasive, the rejection is maintained.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
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 extension fee 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 TITILAYO MOLOYE whose telephone number is (571)270-1094. The examiner can normally be reached Working Hours: 5:30 a.m-3:00 p.m. M-F. Off first Friday of biweek.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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