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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claimed in claims 6,9,11,16,33,37,40,43,46,50, 54, 64, 74, 75 and 77 in the reply filed on 7/5/22 was previously acknowledged. Election was made of CAR (second protein domain), ER domain and SEQ ID NO: 58 (degradation domain), Bazedoxifene (stabilization compound), Furin cleavage site, 4-IBB (CD137)(costimulatory signaling domain), CD3-zeta stimulatory domain (primary signaling domain), scFV (antigen binding domain) and antigen binding domain that binds CLEC12A.
In the reply filed 1/12/24, Applicants amended claims 6, 9, 11, 16, 33, 43, 46, 50, 54,64,65, 75, 77, 87, 90, 93, 99, 104 and 112. Claims 19, 22, 40, 96, 100, 107, 109, 118, 120, 158 and 160 were canceled. Claims 167-182 were added.
In the reply filed 10/1/24, Applicants amended claims 6,16, 54, 77 and canceled claim 9.
In the reply filed 10/22/25, Applicants amended claims 6, 16, 37, 43, 50, 167-169 and 174. Claim 11 was canceled.
In the reply filed 7/9/26, Applicants amended claims 6, 33 and 173.
Claims 6, 16, 33, 37, 43, 46, 50, 54, 64, 65, 69-70, 73, 74, 75, 77, 87, 90, 93, 99, 104, 111-112 and 167-169, 171-182 are pending.
Claims 87, 90, 93, 99, 104, 111, 112, 171-172, 178 and 179 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Please note that claims 170 and 172 are withdrawn because furin (elected species) is not a mammalian extracellular protease. The species of CD19 was found so the species was extended to claim 175.
Applicants argue in the response filed 10/22/25 that the claim 170 should not withdrawn because the elected species of “furin” can localize and function extracellularly. Applicants argue that Zhang et al. (submitted in ids filed 10/22/25) discloses that furin extracellularly cleaves secreted PTEN and states furin also exists in the extracellular space.
The Examiner disagrees that furin is classified as both an intra and extracellular protease and the instant specification does not define it as such. Nevertheless, in view of compact prosecution, claim 170 will be rejoined. Please note that claims 69-70 and 73 are also rejoined because the nucleic acid, vector and viral particle are taught by the cited prior art.
Claims 6, 16, 33, 37, 43, 46, 50, 54, 64-65, 69-70, 73-75, 77, 167-170, 173-175, 176-177 and 180-182 are under consideration.
Claim Rejections - Withdrawn
The rejection of claims 6, 16, 33, 37, 43, 46, 50, 54, 64-65, 69-70, 73-75, 77, 167-170, 173-177 and 180-182 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 is withdrawn due to amendment of the claims and Applicants arguments.
The rejection of claims 6, 16, 33, 37, 64, 69-70, 73-75, 77, 167-170, 180 and 182 under 35 U.S.C. 103 as being unpatentable over Wandless et al. (USPN 8,173,792) in view of Heuser et al. (Gene Therapy 2003, 10. 1408-1419) and Chen et al. (Adv Drug Deliv Rev. PMC 2014) is withdrawn due to amendment of the claims and Applicants arguments.
The rejection of claims 6, 16, 33, 37,43, 46,50, 54, 64, 69-70, 73-75, 77, 167-170, 173-176 and 180-182 under 35 U.S.C. 103 as being unpatentable over Wandless et al. (USPN 8,173,792), Heuser et al. (Gene Therapy 2003, 10. 1408-1419) and Chen et al. (Adv Drug Deliv Rev. PMC 2014) in view of Bedoya et al. (USPN 10,273,300) is withdrawn due to amendment of the claims and Applicants arguments.
The rejection of claims 6, 16, 33, 37,43, 46,50, 54, 64, 65, 69-70, 73-75, 77, 167-170, 173-177 and 180-182 under 35 U.S.C. 103 as being unpatentable over Wandless et al. (USPN 8,173,792), Heuser et al. (Gene Therapy 2003, 10. 1408-1419), Chen et al. (Adv Drug Deliv Rev. PMC 2014) and Bedoya et al. (USPN 10,273,300) in view of Schonfeld et al. (EP3115373) is withdrawn due to amendment of the claims and Applicants arguments.
Double Patenting-Maintained
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.
The rejection of claims 6, 16, 33, 37, 43, 46, 50, 54, 64-65, 69-70, 73-75, 77, 167-170, 173-175, 176-177 and 180-182 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11,999,802 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because the USPN claims a fusion protein comprising a CRBN binding polypeptide and a CAR (claim 1), wherein the fusion protein further comprises a degradation domain (claim 5), wherein the fusion protein comprises a degradation domain, a heterologous protease cleavage site, the CAR and a CRBN binding peptide (claim 6), wherein the degradation domain is an ER domain (claims 16-17), wherein the heterologous cleavage site is a furin site (claims 24-26), wherein the degradation domain is an FKBP domain of DHFR domain (claims 28-32). Therefore, the USPN claims a fusion protein comprising a CAR, the same degradation domains as instantly claimed and a heterologous protease site. Please note the claim language of claim 6 is open and therefore does not preclude other components to the fusion protein. Therefore, the USPN anticipates the instant claims.
Response to Arguments
Applicant's arguments filed 7/9/26 have been fully considered but they are not persuasive. Applicants request the rejection be held in abeyance until the outstanding rejections are overcome.
This argument is not persuasive. As indicated in the interview summary, Applicant was advised that a terminal disclaimer was required to procced to allowance; however Applicant declined to file the terminal disclaimer and instead requested issuance of an Office Action.
Conclusion
No claims are 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 TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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