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 .
Amendments
In the reply filed 1/30/2026, Applicant has amended Claims 1, 4, 9, 11-1318, 21-25, 27-28, and cancelled Claims 8 and 17.
Claims 1-7, 9-16, 18-29 are under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/25/2025 and 1/30/2026 were filed after the mailing date of the non-final Office action on 8/01/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawn Claim Objections
The objection to Claim 9 have been withdrawn due to applicant’s amendment.
Withdrawn Claim Rejections 35 USC § 112(d)
The prior rejection of Claim 27* under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, is withdrawn in light of Applicant amendments to limit the gRNA of the first RNP complex to target a region in the B2M gene. *Note that the header of the non-final Office action erroneously indicated Claim 28.
Withdrawn Claim Rejections - 35 USC § 103
The prior rejection of Claims 1-4, 6-7, 9-12, 14, and 26 under 35 U.S.C. 103 as being unpatentable over Krammer et al., (WO 2013/159879, filed 4/17/2103, see IDS filed 8/22/2022), in view of Denu et al., (OMCL, 2016, 1:1-9, see IDS filed 8/22/2022), Busser et al., (WO 2019/076486, filed 3/09/2018, see IDS filed 8/22/2022) and Meissner (US2019/0309259, filed 5/09/2016, published 10/10/2019, see IDS filed 8/22/2022) is withdrawn in light of Applicant’s amendments to claim 1 to limit the PD-L1 sequence of SEQ ID NO:11 and/or the HLA-E sequence of SEQ ID NO:55.
The prior rejection of Claim 5 under 35 U.S.C. 103 as being unpatentable over Krammer et al., (WO 2013/159879, filed 4/17/2103, see IDS filed 8/22/2022), in view of Denu et al., (OMCL, 2016, 1:1-9, see IDS filed 8/22/2022), Busser et al., (WO 2019/076486, filed 3/09/2018, see IDS filed 8/22/2022) and Meissner (US2019/0309259, filed 5/09/2016, published 10/10/2019, see IDS filed 8/22/2022), as applied to claims 1 and 4, in further view of Zhang et al., (US 8,906,616, filed 5/29/2014, see IDS filed 8/22/2022) is withdrawn in light of Applicant’s amendments to claim 1.
The prior rejection of Claims 19 and 20 under 35 U.S.C. 103 as being unpatentable over Krammer et al., (WO 2013/159879, filed 4/17/2103, see IDS filed 8/22/2022), in view of Denu et al., (OMCL, 2016, 1:1-9, see IDS filed 8/22/2022), Busser et al., (WO 2019/076486, filed 3/09/2018, see IDS filed 8/22/2022) and Meissner (US2019/0309259, filed 5/09/2016, published 10/10/2019, see IDS filed 8/22/2022), as applied to claim 1, in further view of Cowan et al. (WO2016/183041, filed 5/09/2016, see IDS filed 8/22/2022) and Garry et al., (US 2014/0271580, filed 3/14/2013, see IDS filed 02/08/2023) is withdrawn in light of Applicant’s amendments to claim 1.
The prior rejection of Claims 21, 22, 24, and 25 under 35 U.S.C. 103 as being unpatentable over Krammer et al., (WO 2013/159879, filed 4/17/2103, see IDS filed 8/22/2022), in view of Denu et al., (OMCL, 2016, 1:1-9, see IDS filed 8/22/2022), Busser et al., (WO 2019/076486, filed 3/09/2018, see IDS filed 8/22/2022) and Meissner (US2019/0309259, filed 5/09/2016, published 10/10/2019, see IDS filed 8/22/2022), as applied to claim 1, in further view of Berk et al., (US 8,999,944, filed 1/20/2006, see IDS filed 8/22/2022) and Zhang et al., (US 2016/0175462, filed 12/16/2015, see IDS filed 02/08/2023) is withdrawn in light of Applicant’s amendments to claim 1.
Terminal Disclaimer
The terminal disclaimer filed on 1/30/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patents 11,118,196 and 11,104,918 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Double Patenting
The prior rejection of Claims 1, 3-16, 18-29 on the grounds of nonstatutory double patenting over claims 1-25 of U.S. Patent No. 11,118,196 (Rezania et al., Patented 9/14/2021) is withdrawn in light of the terminal disclaimer filed 1/30/2026.
The prior rejection of Claims 2 and 3 on the grounds of nonstatutory double patenting over claims 1-25 of U.S. Patent No. 11,118,196 (Rezania et al., Patented 9/14/2021) is withdrawn in light of the terminal disclaimer filed 1/30/2026.
The prior rejection of Claims 1-7, 9-16, 18-29 on the grounds of nonstatutory double patenting over claims 1-28 of U.S. Patent No. 11,104,918 (Rezania et al., Patented 8/31/2020) is withdrawn in light of the terminal disclaimer filed 1/30/2026.
Maintained 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-5, 9-12, 14, 17-22, and 24-26 stand rejected on the grounds of nonstatutory double patenting over claims 1-22 of U.S. Patent No. 11,566,230 (Rezania et al., Patented 1/31/2023).
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the method for generating genetically modified stem cells of cited patent makes obvious the method of instant application. It is clear that elements of the cited patent claims are to be found in instant claims. The difference between cited patent claims and instant claims is that cited patent claims do not explicitly claims that the RNA-guided nuclease and the gRNA are in a complex. Nevertheless, when introducing these elements into the stem cells of cited patent, it would have been obvious to co-deliver these elements so as allow them to form a complex.
Since the instant application claims are made obvious by cited patent claims, said claims are not patentably distinct.
Claims 1-7, 9-12, 14-16, 18-22, 24-27 stand provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/177,703 (which is a CON of US 11,566,230). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method for generating genetically modified stem cells of cited application makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims do not explicitly claims that the RNA-guided nuclease and the gRNA are in a complex. Nevertheless, when introducing these elements into the stem cells of cited application, it would have been obvious to co-deliver these elements so as allow them to form a complex.
Since the instant application claims are obvious over cited application claims, said claims are not patentably distinct.
Response to Arguments
Applicant's arguments filed on 1/30/2026 are acknowledged.
Applicant argues that instant application has a patent term date extending back to 9/4/2020, while cited patent US 11,566,230, as well as cited application 18/177,703 (which is a CON of US 11,566,230) were filed with patent term dates of 12/31/2021. Since instant application has the earlier patent term date, Applicant argues the obvious type double patenting with cited patent and cited copending application should be withdrawn.
Applicant's arguments have been fully considered but they are not persuasive.
While the Examiner agrees that the provisional obvious double patenting (ODP) rejection over 18/177,703 would be withdrawn if it was the only rejection remaining, MPEP 804 I.1.(a) indicates that the terminal disclaimer does not just affect patent term but is also to prevent possible harassment by multiple assignees (see ¶8.33 Heading for Nonstatutory Double Patenting). In other words, terminal disclaimers can ensure:
Common Ownership: The disclaimer binds the patent to the reference patent for its entire term, requiring that both patents remain under common ownership for the disclaimer to be valid.
Enforceability: A terminal disclaimer often includes a condition that the patent is only enforceable if it is commonly owned or enforced with the reference patent.
Licensing Constraints: The limitation to common ownership means that selling or exclusively licensing the patent separately from the reference patent can render it unenforceable.
Combined Risk: Because of the common ownership requirement, if one patent in the chain is found to be invalid, it can complicate the enforcement of the others.
Furthermore, there is established legal precedent for ODP as not being limited to patent applications filed later than the reference patent. The Federal Circuit has repeatedly sustained ODP rejections where the reference patent has a later priority and patent-term filing date than the application under examination. The cases look not to the relative filing dates of the patents, but to whether the claims are patentably indistinct and whether the relationship between the patents creates the risks ODP exists to prevent. For example, In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009), speaks directly this point. The application on appeal was a continuation filed in 2003, with a priority and patent-term filing date of 1997. Id. at 1315. The ODP reference patents had later priority and patent-term filing dates (1998 and 1999) and issued in 2002, before the continuation was filed. The Federal Circuit affirmed the Board's ODP rejection based on these later-priority reference patents. Id. at 1319. The court acknowledged that "the unjustified patent term extension justification for obviousness-type double patenting has limited force in this case," but it identified a "second justification for obviousness-type double patenting-harassment by multiple assignees." Id. at 1318-19 (citing In re Van Ornum, 686 F.2d 937, 944-48 (C.C.P.A. 1982)). This problem could not be cured by a terminal disclaimer because the patents were not commonly owned. Id. at 1319. The Federal Circuit affirmed a similar ODP rejection in In re Hubbell, 709 F.3d 1140 (Fed. Cir. 2013). There, the reference patent also had a later priority and patent-term filing date than the application under examination. See id. at 1142 (citing U.S. Patent No. 7,601,685 (reference patent, with priority and effective patent-term filing date of Aug. 27, 1998); U.S. Patent Application No. 10/650,509 (application at issue, claiming priority to 1997, with patent-term filing date of Apr. 2, 1998)). The Federal Circuit again affirmed the ODP rejection, stating that "the multiple assignee harassment justification adopted in Van Ornum and reaffirmed in Fallaux.”
As in those cases, the reference patent here has later priority dates and later expiration dates than the application under examination. As in those cases, the application and reference patents share common inventors. And as in those cases, the applicant could have sought the claims at issue earlier but chose not to do so.
As the Federal Circuit recognized in Cellect, even a patent owner's promise not to divide ownership does not "suffice[] to abrogate the potential future risk of multiple
owners." In re Cellect, LLC, 81 F.4th 1216, 1230 (Fed. Cir. 2023). Indeed, the anti-harassment rationale applies with particular force when, as here, when patentably indistinct patents arise from separate application families with different priority dates. There is less inherent structural reason for such patents to remain commonly owned, increasing the risk that the patents end up in different hands. Adopting the Applicant’s arguments would immunize earlier-filed applications from ODP based on later-filed reference patents regardless of whether the patents share a common priority chain, increasing the risk of the harassment that ODP is designed to prevent.
Allowable subject matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not teach or fairly suggest a B2M targeting vector comprising the sequence consisting of SEQ ID NO:33. Specifically, Applicant’s method comprises the novel targeting vectors termed “B2M-CAGGS-PDL1” (see Fig. 3 of the drawings) that targets the PDL1 transgene to the human B2M gene in chromosome 15.
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art does not teach or fairly suggest a HLA-E targeting vector comprising the sequence consisting of SEQ ID NO:34 or 56. Specifically, Applicant’s method comprises the novel targeting vectors termed “TNXIP-CAGGS-HLA-E” (see Fig. 14 of the drawings) that targets the HLA-E transgene to the human TNXIP gene in chromosome 1. These targeting vectors are nearly identical with the exception that SEQ ID NO:34 comprises a full length chimeric intron, while SEQ ID NO:56 comprises a truncated chimeric intron (see Tables 10 & 11 of specification).
Claims 28-29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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