DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 13-27 are pending and under consideration.
Priority
The instant application is a CON of US Application No. 14/413,100 which is a 371 of PCT/US2013/050293.
Information Disclosure Statement
The information disclosure statements (2) filed on 7/29/2024 have been considered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 13, 17 and 27 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by JP 2004529636.
The instant claims are directed to a method for treating an autoimmune disease in a subject in need thereof, the method comprising administering an effective amount of a cell genetically modified to express a chimeric antigen receptor (CAR) to the subject, wherein the CAR comprises an antigen binding domain, a costimulatory signaling region, and a CD3 zeta signaling domain, wherein the antigen binding domain targets a B cell surface marker, thereby depleting B cells in the subject, wherein the B cell marker is CD19 (claim 17) and wherein the cell genetically modified to express the CAR is a T cell.
JP 2004529636 teaches a genetically engineered immune cell for immunotherapy (Paragraph [0002]). They teach an engineered chimeric antigen receptor (CAR) comprising of a single chain antibody fused to intracellular domain of zeta chain of the T cell receptor and the reference teaches that the CAR is to target B cell mediated autoimmune diseases (paragraph [0016]). JP 2004529636 teaches that the CAR is CD19 specific (see paragraph [0025] and claims 1-3). Therefore, the instantly claimed invention is implicitly or explicitly anticipated by the prior art.
Claim(s) 13-27 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by June et al. (US Pat. No. 9,499,629, also published as US20130287748A1 claims priority to US 61/421,470 filed on 12/9/2010).
The instant claims are broadly drawn to a method for treating an autoimmune disease in a subject in need thereof, the method comprising administering an effective amount of a cell genetically modified to express a chimeric antigen receptor (CAR) to the subject, wherein the CAR comprises an antigen binding domain, a costimulatory signaling region, and a CD3 zeta signaling domain, wherein the antigen binding domain targets a B cell surface marker, thereby depleting B cells in the subject (claim 13),
wherein the autoimmune disease is systemic lupus erythematosus (SLE) (claim 14), wherein the cell is detectable in the subject for at least eighteen months after administration to the subject (claim 15), wherein the B cells are Breg cells (claim 16), wherein the B cell marker is CD19 (claim 17), wherein the antigen binding domain comprises the amino acid sequence of SEQ ID NO: 20 (claim 18), wherein the costimulatory signaling region comprises a 4-1BB intracellular costimulatory signaling region (claim 19), wherein the 4-1BB intracellular costimulatory signaling region comprises the amino acid sequence of SEQ ID NO: 23 (claim 20), wherein the CD3 zeta signaling domain comprises the amino acid sequence of SEQ ID NO: 24 (claim 21). The method of claim 13, wherein the CAR further comprise a CD8 transmembrane domain (claim 22), wherein the CD8 transmembrane domain comprises the amino acid sequence of SEQ ID NO: 22 (claim 23), wherein the CAR further comprise a CD8 hinge (claim 24), wherein the CD8 hinge comprises the amino acid sequence of SEQ ID NO: 21 (claim 25), wherein the CAR comprises the amino acid sequence of SEQ ID NO: 12 (claim 26), and wherein the cell genetically modified to express the CAR is a T cell (claim 27).
Regarding claim 13, June et al teach a chimeric receptor comprising an anti-CD19 CAR including both CD3-zeta and the 4-1BB costimulatory domain (also referred to as CART19 cells) (see col. 10, lines50+). The CAR comprises amino acid sequence of SEQ ID NO: 12 is 100% identical to the amino acid sequence of SEQ ID NO: 12 of the reference June et al. (US Pat. No. 9,499,629) (see search result in US-18-332-150-12.rai of 2/9/2026). Regarding claim 18, it is noted that the amino acid sequence of SEQ ID NO: 12 comprises amino acid sequence of SEQ ID NO:20. Regarding claims 19-20, the CAR comprising amino acid sequence of SEQ ID NO: 12 comprises 4-1 BB signaling domain (col. 12, line 51). Regarding claim 21, the CAR comprising amino acid sequence of SEQ ID NO: 12 also comprises the CD3 zeta signaling domain comprising the amino acid sequence of SEQ ID NO: 24, and the CAR of the prior art is 100% identical to the instantly claimed CAR. June et al. teach that the composition comprising T cell comprising a single chain chimeric receptor is for treating immune diseases (col. 10, lines46+). June et al. teach that autoimmune disease includes systemic lupus erythematosus (col. 12, lines54+). Regarding claim 15, June et al teach that T cells persist in the human at least for 4 months, 5 months, 6 months, seven months, eight months, 10 months, 12 months, 2 years, 3 years after administration. June et al do not explicitly teach that B cells being reduced are B reg cells but because the composition taught by June et al is the same the in vivo effect in the patient would be the same, unless evidence to contrary. Therefore, the instantly claimed invention is implicitly or explicitly anticipated by the prior art of record.
“Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)
The applied reference has a common assignee with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
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 13-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-10, 13-14, 25, 34-38, 42-43, and 52 of U.S. Patent No. 9,499,629. Although the claims at issue are not identical, they are not patentably distinct from each other because a method of treating a disease in human comprising administering a CAR of amino acid sequence of SEQ ID NO: 12, wherein the CD19 antigen binding fragment comprises amino acid sequence of SEQ ID NO: 20, wherein CD8 comprises amino acid sequence of SEQ ID NO: 22,wherein the 4-1BB comprises amino acid sequence of SEQ ID NO: 23, and wherein the T cells persist in vivo for at least 18 months are taught in claims 1-5, 8-10, 13-14, 25, 34-38, 42-43, and 52 of U.S. Patent No. 9,499,629, and wherein composition can be used for treating inflammatory diseases including SLE are disclosed as preferred embodiment (col. 12, lines 54+).
Conclusion
No claim is allowed.
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/GYAN CHANDRA/ Primary Examiner, Art Unit 1674