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 in the reply filed on 02 February 2026 is acknowledged.
The restriction requirement from 03 December 2025 is withdrawn and all groups are rejoined.
Claim Status
Claims 1-20 as filed on 02 February 2026 are pending and under examination.
The Examiner for this application has changed, please address all future communications to Francesca Edgington-Giordano AU 1643.
Information Disclosure Statement
The information disclosure statement filed 10 December 2022 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the NPL reference was not attached. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 1-2, 5-6, and 10-12 are objected to because of the following informalities:
Claim 1 recites “A chimeric antigen receptor, comprises” where it should recite “A chimeric antigen receptor comprising” in line 1.
Claim 10 recites “A nucleic acid construct, comprises . . .” where is should recite “A nucleic acid construct, comprising . . .” in line 1.
Claim 11 recites “A lentivirus vector system, comprises . . .” where it should recite “A lentivirus vector system, comprising . . .” in line 1.
Claims 12 and 15 recites “A genetically modified T cell, comprises the nucleic acid . . .” where is should recite “A genetically modified T cell, comprising the nucleic acid . . .” in line 1.
Claims 2 and 4-6 recite “. . . further comprises . . .” when referring to elements already required by claims. The claims should recite “The chimeric antigen receptor according to claim 1, wherein the following:”, “The chimeric antigen receptor according to claim 3, wherein one or more of the following:” etc.
Claims 5-6 has internal periods after bullet points a-c. Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v. Manbeck, 36 USPQ2d 1211 (D.D.C. 1995); MPEP 608.01(m).
Claim 5 requires one or more of bullets a and b. The end of line 4 of bullet a should recite “and/or”.
Claim 6 requires one or more of bullets c and d. The end of line 1 of bullet c should recite “and/or”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13-14 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
The claims are directed to “use” and as written the “of use” claims do not recite a claim within one of the statutory classes (see MPEP 2106). The claims are not to a method as they do not recite active method steps and are not to a composition. "Use" claims are non-statutory under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki , 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). See MPEP 2173.05(q).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8, and 10-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salter (WO 2020068702 A1) (IDS).
Regarding claims 1-3, Salter teaches a chimeric antigen receptors (CAR) that comprises an extracellular domain comprising an antigen recognition region, a transmembrane domain, and an intracellular domain which are connected in sequence (e.g. see page 6, lines 13-17). Salter teaches that the extracellular domain comprises a hinge region (e.g. see page 39, lines 21-30). Salter teaches that one end of the intracellular domain which is connected to the transmembrane domain and comprises an effector domain or a functional portion or variant thereof, wherein the effector domain or functional portion thereof may comprise an (i) Intracellular Tyrosine-based Activation Motif (ITAM) from CD3ε, or a functional portion or variant thereof, (ii) a Basic Residue Rich Sequence (BRS) from CD3ε, or a functional portion or variant thereof; or (iii) any combination of (i)-(iii) (e.g. see page 6, lines 18-24). Salter teaches that the intracellular domain comprises a costimulatory domain and a CD3ζ intracellular segment that are sequentially connected, wherein the costimulatory domain is CD27, CD28, CD134, 4-1BB, OX40, and ICOS (e.g. see page 35, line 30 – page 36, line 4). Salter teaches an exemplary BRS from CD3ε is provided in SEQ ID NO: 9 (KNRKAKAK) and an exemplary sequence of a human CD3ε cytoplasmic domain containing is SEQ ID NO: 111 which matches instant SEQ ID NO: 1 and is shown below (KNRKAKAKPVTRGAGAGGRQRGQNKERPPPVPNPDYEPIRKGQRDLYSGLNQRRI).Salter teaches that the intracellular domain comprises a costimulatory domain and a CD3ζ intracellular segment that are sequentially connected, wherein the costimulatory domain is CD27, CD28, CD134, 4-1BB, OX40, and ICOS (e.g. see page 35, line 30 – page 36, line 4).
Regarding claim 4, Salter teaches the CD3 ζ that matches instant SEQ ID NO: 3 for use in a CAR in SEQ ID NO: 29. Claim 3 only requires one of the sequences recited.
Regarding claims 5-6, Salter teaches that extracellular domain comprises a CD19-specific scFv derived from FMC63 (e.g. see page 33, lines 13-20) and a CD28 transmembrane domain (page 37 in line 5) and further teaches instant SEQ ID NO: 4 in SEQ ID NO: 29. Salter further teaches the scFv binds the cancer antigen of mesothelin (claim 29).
Regarding claims 8 and 10-11, Salter teaches a lentiviral vector that encodes in a host cell the proteins of the invention (page 46 in lines 24-31 and page 47 in lines 1-5).
Regarding claim 12, Salter teaches a modified T cell that expressed the fusion protein (page 62 in lines 1-4).
Regarding claims 13-15 and 17-18, Salter teaches a modified T cell that comprises a polynucleotide that encodes the CAR of the Salter and the instant claims for use in manufacturing a medication for a disease (Embodiment 81 page 86) or for the treatment of cancer (Embodiments 82-83 in page 86). The preparation of modified T cells would fulfill the requirement of subpart 1 of claims 17-18.
Regarding claim 16, Salter teaches lentiviral vectors in host cells (page 46 in lines 24-31 and page 47 in lines 1-5) and teaches host cells include T cells (Embodiment 81 page 86).
Regarding claims 19-20, Salter teaches the use of the modified cells in the treatment of cancer (Embodiments 82-83 in page 86).
Regarding claim 8, Salter teaches a lentiviral vector that encodes in a host cell the proteins of the invention (page 46 in lines 24-31 and page 47 in lines 1-5).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Salter (WO 2020068702 A1) (IDS), Suri (WO 2018161017 A1) (PTO-892), Zhang et. al. Immunotherapy. 10(11):935-949. (2018) (PTO-892), and Zhang et. al. Biomarker Research 5(22):1-6. (2017) (“Zhang 2017” PTO-892).
Claim 7 requires a CAR of SEQ ID NO: 5 and claim 9 requires a nucleic acid that encodes the CAR of SEQ ID NO: 5. The component of SEQ ID NO: 5 is shown below in Figure 1a of the disclosure. SEQ ID NO: 5 is 812 amino acids in length and is Anti-CD19 E28z CAR
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Amino acids 1 to 292 would be a tag of HA, a self-cleavage of T2A and GFP and
SEQ ID NO: 5 comprises:
scFv from amino acids 292-536 taught in Salter in SEQ ID NO: 102;
Amino acids 537 to 578 is wildtype CD28 hinge;
instant SEQ ID NO: 4 from 579 to 605 is wildtype CD28 TM;
instant SEQ ID NO: 1 in 606 to 660 CD3 epsilon;
instant SEQ ID NO: 2 661-701 is wildtype CD28 intracellular;
instant SEQ ID NO: 3 702 to 813 is wildtype CD3 zeta.
Regarding claim 1, Salter teaches a chimeric antigen receptors (CAR) that comprises an extracellular domain comprising an antigen recognition region, a transmembrane domain, and an intracellular domain which are connected in sequence (e.g. see page 6, lines 13-17). Salter teaches that the extracellular domain comprises a hinge region (e.g. see page 39, lines 21-30). Salter teaches that one end of the intracellular domain which is connected to the transmembrane domain and comprises an effector domain or a functional portion or variant thereof, wherein the effector domain or functional portion thereof may comprise an (i) Intracellular Tyrosine-based Activation Motif (ITAM) from CD3ε, or a functional portion or variant thereof, (ii) a Basic Residue Rich Sequence (BRS) from CD3ε, or a functional portion or variant thereof; or (iii) any combination of (i)-(iii) (e.g. see page 6, lines 18-24). Salter teaches that the intracellular domain comprises a costimulatory domain and a CD3ζ intracellular segment that are sequentially connected, wherein the costimulatory domain is CD27, CD28, CD134, 4-1BB, OX40, and ICOS (e.g. see page 35, line 30 – page 36, line 4). Salter teaches an exemplary BRS from CD3ε is provided in SEQ ID NO: 9 (KNRKAKAK) and an exemplary sequence of a human CD3ε cytoplasmic domain containing is SEQ ID NO: 111 which matches instant SEQ ID NO: 1 and is shown below (KNRKAKAKPVTRGAGAGGRQRGQNKERPPPVPNPDYEPIRKGQRDLYSGLNQRRI).
Regarding claims 7 and 9, Salter teaches the CD19 binding scFv in SEQ ID NO: 102 which is FMC63 which matches amino acids 292-536 of instant SEQ ID NO: 5 (page 33 in lines 13-20). Salter teaches the use of multiple tags for tracking proteins including GFP and HA (page 40 in lines 16-31) and the cleavage sequence T2A (page 46 in lines 1-13).
By teaching the scFv of instant SEQ ID NO: 5, a CD28 hinge, CD28 transmembrane domain, the CD3ε of the claims, CD28 intracellular domain, and CD3 zeta domain Salter teaches to one of skill in the art the wildtype sequences of these known domains and thus Salter teaches amino acids 292 to 813 of instant SEQ ID NO: 5. Salter teaches T2A, GFP, and HA with the CAR of their invention.
Salter does not teach the signal peptide or SP of instant SEQ ID NO: 5.
This deficiency is filled Suri, Zhang, and Zhang 2020.
Suri teaches signaling peptides of MLLLVTSLLLCELPHPAFLLIP in SEQ ID NO: 1031 which is the signaling peptide of instant SEQ ID NO: 5 ([00294]).
Suri teaches varying sequence orders including signal peptide, which is SS in Suri, between payload which would be the tag sequences and CAR fusion protein as shown in Figure 1 of the instant application in Suri’s Figures 4-7 and Figure 15. Suri teaches the cleavage sites include T2A of instant SEQ ID NO: 5 ([00298]). Suri teaches the use of different scFvs including the CD19 binding FMC63 antibody of the claims (claim 21 and [0046]).
Zhang teaches tumor therapy using CD19 CAR T cells that comprise the signal peptide MLLLVTSLLLCELPHPAFLLIP (page 938 in par 5 and Figure 1). Zhang teaches the CAR T cell comprising the signal peptide of instant SEQ ID NO: 5 is effective in tumor immunotherapy with high cytotoxicity (abstract).
Zhang 2017 teaches the use of signal peptide in the ectodomain of a CAR to direct the protein to the endoplasmic reticulum (page 1 in col 2 in par 1 and Figure 1). Zhang 2017 teaches the use of signal peptides in first to fourth generation CARs (Figure 2).
It would have been obvious at the time the application was filed to combine the CAR fusion peptide of Salter that comprises multiple tag peptides of eGFP and HA and a T2A cleavage sequence with a CAR of amino acids 292 to 813 of instant SEQ ID NO: 5 with the signaling peptide of MLLLVTSLLLCELPHPAFLLIP taught by Suri and Zhang. One of skill in the art would have been motivated to combine the CAR fusion of Salter with signal peptide to direct it to the endoplasmic reticulum for a more effective CD19 CAR T cell. There would have been a reasonable expectation of success as Zhang 2017 teaches the use of signal peptides in the different CAR T generations and Suri and Zhang teaches the use of the signal peptide of instant SEQ ID NO: 5 in CD19 CAR Ts including ones comprising the FMC63 scFv of the instant claims.
Claims 1, 5-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Salter (WO 2020068702 A1) (IDS), Suri (WO 2018161017 A1) (PTO-892), Zhang et. al. Immunotherapy. 10(11):935-949. (2018) (PTO-892), and Zhang et. al. Biomarker Research 5(22):1-6. (2017) (“Zhang 2017” PTO-892) as applied to claims 1 and 7-9 above, and further in view of Lim (US 10590182 B2) (PTO-892).
The teachings of Salter from the previous 103 rejection are incorporated here in full.
Salter further teaches the scFv binds the cancer antigen of mesothelin (claim 29).
The teachings of Suri, Zhang, and Zhang 2017 are incorporated here in full.
Salter in view of Suri, Zhang, and Zhang 2017 teaches the CD19 binding CAR T cell of instant SEQ ID NO: 5 as previously described.
Salter in view of Suri, Zhang, and Zhang 2017 does not teach the scFv of SS1 in instant SEQ ID NO: 6.
This deficiency is filled by Lim.
Lim teaches a CAR that binds mesothelin and comprises the scFv of SS1 of instant SEQ ID NO: 10 found in instant SEQ ID NO: 6 in SEQ ID NO: 91 (col 109 in lines 35-46).
It would have been obvious to substitute the generic mesothelin binding scFv of Salter with the scFv of Lim to produce a CAR T cell of instant SEQ ID NO: 6. One of skill in the art would have been motivated to substitute the generic scFv that binds mesothelin with the known to work in a CAR scFv of Lim. There would have been a reasonable expectation of success as it would be a substitution of a generic scFv with a specific functional scFv.
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 1-6, 8, 10-12, and 15-16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18017696 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 5-6, The reference application recites a CAR comprising an scFv of FMC63 that binds CD19 (claim 6), a CD28 hinge (claim 5), a CD28 transmembrane domain (claim 6), a CD3ε domain, a CD28 costimulatory domain, and a CD3ζ domain (claims 1-3). The reference application recites the order of transmembrane domain to CD3ε domain, costimulatory domain, and a intracellular domain (claims 1-2).
Regarding claim 2, the reference application recites the mutations in SEQ ID NO: 1 that would result in it matching instant SEQ ID NO: 1 (claim 2).
Regarding claims 3-4, the reference application recites SEQ ID NO: 2 and SEQ ID NO: 3 which both instant SEQ ID NO: 2 and instant SEQ ID NO: 3, respectively and recites both in the CAR (claim 4).
Regarding claims 8, 10-12, 15-16, the reference application recite a lentiviral vector in a genetically modified T cell where the vector encodes a polynucleotide of the CAR of the instant claims (claims 8 and 10-12).
Regarding claims 13-14 and 17-20, the reference application recites the preparation of T cells and preparation of tumor treatment products (claims 13-14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18017696 (reference application) in view Salter (WO 2020068702 A1) (IDS), Suri (WO 2018161017 A1) (PTO-892), Zhang et. al. Immunotherapy. 10(11):935-949. (2018) (PTO-892), and Zhang et. al. Biomarker Research 5(22):1-6. (2017) (“Zhang 2017” PTO-892)
The recitations of the reference application from the previous rejection are incorporated here in full.
The reference application recites the scFv, the hinge, the transmembrane domain, the CD3ε domain, the costimulatory domain, and the CD3ζ domain (claims 1-3) of instant SEQ ID NO: 5.
The reference application does not recite all elements of instant SEQ ID NO: 5 and 6 or the applications of fusion proteins of instant claims 13-14 and 17-20.
These deficiencies are filled by Salter, Suri, Zhang, and Zhang “2017”.
The teachings of Salter, Suri, Zhang, and Zhang “2017” from the rejections under 35 U.S.C. 102 and 103 are incorporated here in full.
Regarding the sequences of claims 7 and 9, it would have been obvious at the time the application was filed to combine the fusion CAR of the reference application with the multiple tag peptides of eGFP and HA and a T2A cleavage sequence with a CAR of amino acids 292 to 813 of instant SEQ ID NO: 5 with the signaling peptide of MLLLVTSLLLCELPHPAFLLIP taught by Suri and Zhang. One of skill in the art would have been motivated to combine the CAR fusion of reference application with signal peptide to direct it to the endoplasmic reticulum for a more effective CD19 CAR T cell. There would have been a reasonable expectation of success as Zhang 2017 teaches the use of signal peptides in the different CAR T generations and Suri and Zhang teaches the use of the signal peptide of instant SEQ ID NO: 5 in CD19 CAR Ts including ones comprising the FMC63 scFv of the instant claims.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5-7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18017696 (reference application) in view of Salter (WO 2020068702 A1) (IDS), Suri (WO 2018161017 A1) (PTO-892), Zhang et. al. Immunotherapy. 10(11):935-949. (2018) (PTO-892), Zhang et. al. Biomarker Research 5(22):1-6. (2017) (“Zhang 2017” PTO-892), Lim (US 10590182 B2) (PTO-892).
The recitations of the reference application from the previous two double patenting rejections are incorporated here in full.
The reference application recites the hinge, the transmembrane domain, the CD3ε domain, the costimulatory domain, and the CD3ζ domain (claims 1-3) of instant SEQ ID NO: 6 and recites a generic scFv that binds mesothelin (claim 5).
The teachings of Salter, Suri, Zhang, and Zhang “2017” from the previous double patenting and art rejections are incorporated here in full.
The reference application in view of Salter, Suri, Zhang, and Zhang “2017” recites the CD19 binding CAR T cell of instant SEQ ID NO: 5 as previously described.
The reference application in view of Salter, Suri, Zhang, and Zhang “2017” does not recite the scFv of SS1.
This deficiency is filled by Lim.
Lim teaches a CAR that binds mesothelin and comprises the scFv of SS1 of instant SEQ ID NO: 10 found in instant SEQ ID NO: 6 in SEQ ID NO: 91 (col 109 in lines 35-46).
It would have been obvious to substitute the generic mesothelin binding scFv of the reference applciation with the scFv of Lim to produce a CAR T cell of instant SEQ ID NO: 6. One of skill in the art would have been motivated to substitute the generic scFv that binds mesothelin with the known to work in a CAR scFv of Lim. There would have been a reasonable expectation of success as it would be a substitution of a generic scFv with a specific functional scFv.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 5-6, 8, and 10-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19497547(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant SEQ ID NO: 5 matches SEQ ID NO: 6 of the reference application except the truncated CD3ε domain in the reference application instant of the full sequence of instant SEQ ID NO: 1 and used in instant SEQ ID NO: 5.
Instant SEQ ID NO: 6 matches SEQ ID NO: 22 of reference application except the truncated CD3ε domain in the reference application instant of the full sequence of instant SEQ ID NO: 1 and used in instant SEQ ID NO: 6.
The reference application then recites the scFv of FMC63 and SS1.
Reference SEQ ID NO: 6 recites all the elements of the fusion required by instant claims 1 and 5-6.
Regarding claims 8, 10-12, and 15-16, the reference application recites a genetically modified T cell that comprises a lentivirus vector comprising a polynucleotide that encodes the CAR of the instant claims (claims 11-13).
Regarding claims 13-17 and 17-20, the reference application recites the a method of repeating T cells for use in treating cancer (claims 14-15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 7-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable claims 1-19 of copending Application No. 19497547(reference application) in view of Salter.
The recitations of the reference application from the previous double patenting rejection are incorporated here in full.
The reference application does not recite the CD3ε domain of instant SEQ ID NO: 1 and used in instant SEQ ID NO: 5 and 6.
This deficiency is filled by Salter.
The teachings of Salter from the art rejections under 35 U.S.C. 102 and 103 re incorporated here in full.
Salter teaches a CAR comprising a CD3ε domain that matches instant SEQ ID NO: 1 in SEQ ID NO: 111 and further teaches SEQ ID NO: 9 which is the truncated CD3ε domain of the reference claims. Salter teaches the CAR can comprise either the full length CD3ε domain or a functional fragment (page 6, lines 7-9 and 18-24).
It would have been obvious at the time the application was filed to substitute the CD3ε domain of reference application SEQ ID NO: 6 and 22 with the functional CD3ε domain of Salter that matches instant SEQ ID NO: 1. Salter teaches the truncated CD3ε domain of the reference application and the CD3ε domain of instant SEQ ID NO: 1 are art equivalents making their substitution prima facie obvious. There would have been a reasonable expectation of success as the reference application and Salter are both CAR T cells comprising a functional CD3ε domain.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA EDGINGTON-GIORDANO whose telephone number is (571)272-8232. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/F.E./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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