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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-36 have an effective filing date of 11JUN2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/14/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 8/17/2026, Applicant elected, without traverse:
Group I, claims 1-28, 35, and 36
Species
CDRs of SEQ ID NOs: 1-6, CDRs relate to SEQ ID NOs: 25 & 26
Linker of SEQ ID NO: 62
Transmembrane domain is a CD28 polypeptide
Co-stimulatory signaling region is a CD28 polypeptide
Antigen-recognizing receptor is a chimeric antigen receptor (CAR)
Type of cell is a T cell
Status of Claims
Claims 1-36 are currently pending and presented for examination on the merits.
Claims 29-34 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
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 1-28, 35, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9-10, and 16-18 of copending Application No. 18/535,012 ('012) in view of Daniyan et al. (WO 2021/050862, international publication date: 03/18/2021).
With respect to claims 1-5 and 25-27, both the instant and conflicting claims recite: a) an antigen binding fragment comprising SEQ ID NOs: 1,2,3 and 4,5,6 (claim 1), b) is a single-chain variable fragment (scFv), a Fab, or a F(ab)2 (claim 2), c) an antigen binding fragment comprising SEQ ID NOs: 25 & 26 (claims 3-5), d) a nucleic acid encoding SEQ ID NOs: 1,2,3 & 4,5,6 (claim 25), e) a vector comprising SEQ ID NOs: 1,2,3 & 4,5,6 (claim 26), & f) a host cell comprising SEQ ID NOs: 1,2,3 & 4,5,6 (claims 27).
The conflicting claims do not recite an antigen receptor comprising an extracellular antigen-binding domain, a transmembrane domain, and an intracellular signaling domain, wherein the extracellular antigen-binding domain specifically binds to uPAR; however these deficiencies are remedied by Daniyan et al.
At p. 1, Daniyan et al. teach that “[c]ell-based immunotherapy is a therapy with curative potential for the treatment of cancer. T cells and other immune cells may be modified to target tumor antigens through the introduction of genetic material coding for artificial or synthetic receptors for antigen, termed Chimeric Antigen Receptors (CARs), specific to selected antigens.”
Based upon the teachings of Daniyan et al., one of ordinary skill in the art would have been motivated to prepare chimeric antigen receptors that comprise the antigen-binding regions of the conflicting claims. One of ordinary skill in the art would have been motivated to do so, because the resultant chimeric antigen receptors may be used in the treatment of cancer.
With respect to claims 6-14, according to p. 8 of Daniyan et al., said CARs comprise an extracellular region that comprises a heavy chain variable region linked to a light chain variable region via the linker of SEQ ID NO: 91, which shares 100% sequence homology with the instant SEQ ID NO: 2, and Daniyan et al. further teach that the extracellular antigen-binding region may comprise a signal peptide that is covalently joined to the 5’ terminus of the extracellular antigen-binding region. At p. 54, Daniyan et al. teach that CARs of the invention comprise a transmembrane domain of CD8, CD28, or other transmembrane domains recited in the instant claim 9. At p. 59 and 60, Daniyan et al. teach that CARs of the invention comprise an intracellular signaling domain of CD3ζ and one of various co-stimulatory domains, such as CD28, 4-1BB, OX40, ICOS, and DAP-10 polypeptides.
With respect to claims 15-24, 28, 35, and 36, at p. 9 and 10, Daniyan et al. teach that “[i]n certain embodiments, the antigen-recognizing receptor is recombinantly expressed. In certain embodiments, the antigen-recognizing receptor is expressed from a vector. In certain embodiments, the vector is a g-retroviral rector… The presently disclosed subject matter provides cells comprises a presently disclosed antigen-recognizing receptor. In certain embodiments, the cell is transduced with the antigen-recognizing receptor. In certain embodiment, the antigen-recognizing receptor is constitutively expressed on the surface of the cell… In certain embodiments, the cell is engineered to express a cytokine or a fragment thereof. In certain embodiments, the cell further comprises an exogenous polypeptide of the cytokine or fragment thereof. In certain embodiments, the cell further comprises a nucleic acid molecule encoding the cytokine or fragment thereof. In certain embodiments, the cytokine is selected from the group consisting of IL-18, IL-33, IL-36, and combinations thereof. In certain embodiments, the cytokine is IL-18… In certain embodiments, the cell is an immunoresponsive cell. In certain embodiments, the cell is a cell of the lymphoid lineage or a cell of the myeloid lineage… In certain embodiments, the cell is selected from the group consisting of a T cell, a Natural Killer (NK) cell, and a stem cell from which lymphoid cells may be differentiated. In certain embodiments, the cell is a T cell. In certain embodiments, the T cell is a cytotoxic T lymphocyte (CTL) or a regulatory T cell. In certain embodiments, the stem cell is a pluripotent stem cell. In certain embodiments, the pluripotent stem cell is an embryoid stem cell or an induced pluripotent stem cell.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-7 and 9-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, and 4-11 of copending Application No. 19/495,571 ('571) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims recite: a) an antigen binding domain comprising SEQ ID NOs: 1,2,3 & 4,5,6 (claim 1), b) an antigen binding domain comprising SEQ ID NOs: 25 (161) & 26 (162) (claim 3-5), c) a linker between a heavy chain variable region and a light chain variable region (claim 6), d) linker (conflicting SEQ ID NO: 110 shares 100% sequence homology with the instant SEQ ID NO: 62) (claim 7), e) the transmembrane domain comprises identical transmembrane, intracellular signaling, and co-stimulatory domains (claims 9-12), f) is a chimeric antigen receptor (CAR), a T-cell Receptor (TCR), or a T-cell like fusion protein (claims 13 and 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2, 8, 15-28, 35, and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9-10, and 16-18 of copending Application No. 19/495,571 ('571), as applied to claims 1, 3-7 and 9-14, and further in view of Daniyan et al. (WO 2021/050862, international publication date: 03/18/2021).
As indicated above both sets of claims recite: a) an antigen binding domain comprising SEQ ID NOs: 1,2,3 & 4,5,6 (claim 1), b) an antigen binding domain comprising SEQ ID NOs: 25 (161) & 26 (162) (claim 3-5), c) a linker between a heavy chain variable region and a light chain variable region (claim 6), d) linker (conflicting SEQ ID NO: 110 shares 100% sequence homology with the instant SEQ ID NO: 62) (claim 7), e) the transmembrane domain comprises identical transmembrane, intracellular signaling, and co-stimulatory domains (claims 9-12), f) is a chimeric antigen receptor (CAR), a T-cell Receptor (TCR), or a T-cell like fusion protein (claims 13 and 14).
The conflicting claims do not recite immunoresponsive cells that comprise a chimeric antigen receptor; however these deficiencies are remedied by Daniyan et al.
With respect to claims 15-28, 35, and 36, at p. 9 and 10, Daniyan et al. teach that “[i]n certain embodiments, the antigen-recognizing receptor is recombinantly expressed. In certain embodiments, the antigen-recognizing receptor is expressed from a vector. In certain embodiments, the vector is a g-retroviral rector… The presently disclosed subject matter provides cells comprises a presently disclosed antigen-recognizing receptor. In certain embodiments, the cell is transduced with the antigen-recognizing receptor. In certain embodiment, the antigen-recognizing receptor is constitutively expressed on the surface of the cell… In certain embodiments, the cell is engineered to express a cytokine or a fragment thereof. In certain embodiments, the cell further comprises an exogenous polypeptide of the cytokine or fragment thereof. In certain embodiments, the cell further comprises a nucleic acid molecule encoding the cytokine or fragment thereof. In certain embodiments, the cytokine is selected from the group consisting of IL-18, IL-33, IL-36, and combinations thereof. In certain embodiments, the cytokine is IL-18… In certain embodiments, the cell is an immunoresponsive cell. In certain embodiments, the cell is a cell of the lymphoid lineage or a cell of the myeloid lineage… In certain embodiments, the cell is selected from the group consisting of a T cell, a Natural Killer (NK) cell, and a stem cell from which lymphoid cells may be differentiated. In certain embodiments, the cell is a T cell. In certain embodiments, the T cell is a cytotoxic T lymphocyte (CTL) or a regulatory T cell. In certain embodiments, the stem cell is a pluripotent stem cell. In certain embodiments, the pluripotent stem cell is an embryoid stem cell or an induced pluripotent stem cell.”
In view of these teachings, one of ordinary skill in the art would have been motivated to use nucleic acids encoding antigen-binding regions specific for UPAR to prepare immunoresponsive cells, such as T cells, that comprise the conflicting anti-UPAR chimeric antigen receptor. One of ordinary skill in the art would have been motivated to do so, because there would have been a reasonable expectation that said immunoresponsive cells may be used in the treatment of cancer.
With respect to claims 2, at p. 28, Daniyan et al. teach chimeric antigen-binding extracellular domains that are scFv molecules, Fabs, and F(ab)2 molecules.
With respect to claim 8, at p. 8, Daniyan et al. teach that extracellular antigen-binding domains of chimeric antigen receptors may comprise a signal peptide that is covalently joined to the 5’ terminus of the extracellular antigen-binding domain.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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