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
1. The Amendment filed January 29, 2025 in response to the Office Action of October 29, 2025 is acknowledged and has been entered. Claims 1-3, 5, 6, 10-12 14 and 15 have been amended.
2. Claims 1-24 are currently being examined.
Rejections Maintained
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.
3. Claim(s) 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0287748 A1 (June et al. Oct. 31, 2013, IDS), “June” in view of US 2016/0296562 A1 (Pulé et al. Oct. 13, 2016, filed Nov. 21, 2014), “Pulé” for the reasons of record set forth below.
June teaches the present invention provides an isolated nucleic acid sequence encoding a chimeric antigen receptor (CAR), wherein the CAR comprises an antigen binding domain, a transmembrane domain, a costimulatory signaling region, and a CD3 zeta signaling domain, wherein the CD3 zeta signaling domain comprises the amino acid sequence of SEQ ID NO: 24. See ¶ 0005.
SEQ ID NO: 24 comprises the CD3z of the claimed SEQ ID NO: 17. See Appendix.
June teaches that the CAR the antigen binding domain in the CAR can bind CD19, CD20 or both antigen. See ¶¶ 0009, 0021, 0130, 0205, and 0298.
June teaches making and using a CD19 CAR with a FMC63 scFv binding domain. See ¶¶ 0038, 0049, and 0198 and Fig. 1A.
June teaches the CD19 CAR comprises a CD8 leader sequence, a human CD8 alpha hinge and transmembrane domain, and human 4-1BB and CD3 zeta signaling domains. See ¶¶ 0038, 0337 and Fig. 1A and Table 5.
June teaches that the CARs can have 4-1BB or CD28 co-stimulatory domains. See ¶¶ 0010, 0055 and 0059.
June teaches the 4-1BB domain of SEQ ID NO: 23, which comprises the claimed SEQ ID NO: 16. See ¶¶ 0151-0152, Table 5 and the Appendix.
June teaches expressing the CARs in T-cells or NK cells. See abstract and ¶¶ 0014, 0017 and 0173-0182.
June teaches isolated nucleic acids and vectors encoding the CARs of the invention. See ¶¶ 0005-0007, 0001, 0013, 0016, and 0153-0172.
June teaches the 4-1BB domain nucleic acid molecule of SEQ ID NO: 17, which comprises the claimed SEQ ID NO: 60. See ¶¶ 0150-0152, Table 5 and the Appendix.
June teaches the CD3z domain nucleic acid molecule of SEQ ID NO: 18, which comprises the claimed SEQ ID NO: 101. See ¶¶ 0011, 0150, Table 5 and the Appendix.
June teaches expressing the CARs in host cells to make the CAR expressing cells. See ¶¶ 0164-0172.
June teaches treating cancer with the CAR expressing T cells. See abstract, ¶¶ 0019-0022, 0029, 0036, 0052, 0057, 0058, 00203 and 0205 and Example 1.
June teaches the CAR vectors can be administered ex vivo or in vivo. See ¶¶ 0216-0220.
June teaches as set forth above, but does not explicitly teach a working example of a population of cells comprising an FMC63 CAR and a CD20 CAR expressed by a first and a second nucleic acid or a nucleic acid encoding F2A.
Pulé teaches the present invention provides a cell which co-expresses a first chimeric antigen receptor (CAR) and second CAR at the cell surface, each CAR comprising : (i) an antigen-binding domain; (ii) a spacer (iii) a trans-membrane domain; and (iv) an endodomain wherein the antigen binding domains of the first and second CARs bind to different antigens, and wherein each of the first and second CARs is an activating CAR comprising an activating endodomain. See abstract.
Pulé teaches either the first or the second CAR may bind CD19 and the other CAR may bind CD20. Pulé teaches that this is advantageous because some lymphomas and leukemias become CD19 negative after CD19 targeting, so it gives a “back-up” antigen, should this occur. See ¶¶ 0091, 0155, 00228-00230 and Table 4. ...
Pulé teaches single nucleic acid vectors for expression of two distinct CARs separated by an F2A(FMD-2A) sequence. See ¶¶ 0023, 0027, and 0035 and Figs. 4, 8, 12 and 15.
Pulé teaches expressing the CARs in T-cells and NK cells. See ¶¶ 0085 and 0316.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of June and Pulé and express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule separated by an F2A sequence because June teaches the FMC63 CAR and that the CAR the antigen binding domain in the CARs can bind CD19, CD20 or both antigen and Pulé teaches expressing separate CD19 and CD20 CARs separated by an F2A sequence in T-cells and NK cells. One would have been motivated to express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule because Pulé teaches that having the second CAR to CD20 is an advantage because some cancers become CD19 negative after CD19 targeting, so it gives a “back-up” antigen, should this occur.
Response to Arguments
4. Applicant argues that without assenting to the propriety of the rejection and solely to expedite prosecution, Applicants have amended independent claim 1 to recite, inter alia, that the first CAR and the second CAR each comprise an intracellular signaling domain comprising a stimulatory domain and a costimulatory domain. Applicants have amended independent claim 10 in a similar manner.
Applicants respectfully traverse the rejection. The skilled artisan, when starting from Pulé, would not choose to use a first CAR and a second CAR wherein the first CAR and the second CAR each comprise an intracellular signaling domain comprising a stimulatory domain and a costimulatory domain, as required by the instant claims. Pulé relates to "a panel of 'logic-gated' chimeric antigen receptor pairs which, when expressed by a cell, such as a T cell, are capable of detecting a particular pattern of expression of at least two target antigens.' This panel includes "AND" gates ("[the] T cell triggers only when both antigens A and B are present on the target cell"⁷), "AND NOT" gates ("[the] T cell triggers if antigen A is present alone on the target cell, but not if both antigens A and B are present on the target cell"8), and "OR" gates ("[the] T cell triggers when either antigen A or antigen B is present on the target cell""). However, Pulé states that "the T- cell still will activate in the sole presence of the first antigen resulting in the potential for off-target toxicity" and, regarding immunotherapies which target a single antigen, that "[m]ost cancers cannot be differentiated from normal tissues on the basis of a single antigen. Hence, considerable "on-target off-tumour' toxicity occurs whereby normal tissues are damaged by the therapy. Accordingly, Pulé would lead one of skill in the art away from selecting an "OR" gate, and towards selecting a preferred embodiment of Pulé which are an "AND" gate or "AND NOT" gate. Thus, the skilled artisan, based on the teachings of Pulé, would not arrive at the claimed population of cells or nucleic acid molecules comprising a CD19 CAR and a CD20 CAR, wherein the first CAR and the second CAR each comprise an intracellular signaling domain comprising a stimulatory domain and a costimulatory domain because Pulé warned of the potential for toxicity to off-target and non- tumor cells.
Applicant's arguments have been considered, but have not been found persuasive. With regard to Pulé teaching different uses for the first CAR and second CAR, this does not amount to a teaching away because preferred embodiments do not amount to a teaching away from the claimed invention. The disclosure of alternatives does not constitute a teaching away. See MPEP 2123. Additionally, as previously set forth, Pulé teaches, the first and second CARs are activating CARs comprising an activating endodomain. See abstract. Additionally, as previously set forth, Pulé teaches either the first or the second CAR may bind CD19 and the other CAR may bind CD20. See ¶¶ 0091 and 0155. Further, in regard to Applicant’s argument that Pulé teaches away from selecting an "OR" gate, Pulé teaches that the first CAR and second CAR may bind to CD19 and CD20 as an "OR" gate to reduce the probably of the tumor escaping the treatment as seen when only targeting one antigen. See ¶¶ 00228-00230 and Table 4. Thus, clearly Pulé teaches that the first CAR and second CAR may bind to CD19 and CD20 in the "OR" gate configuration which comprises a stimulatory domain and costimulatory domain as shown in Fig. 5. Thus, Applicant’s arguments are not found persuasive and the rejection is maintained.
Independent Claim 17
Applicant argues that independent claim 17 recites an isolated nucleic acid molecule comprising, in a 5' to 3' orientation: a nucleic acid sequence encoding an antigen-binding domain that binds to CD19 comprising a scFv comprising the LC CDR1, LC CDR2, LC CDR3, HC CDR1, HC CDR2, and HC CDR3 of FMC63; a nucleic acid sequence encoding a CD28 transmembrane domain; a nucleic acid sequence encoding a CD28 costimulatory domain; a nucleic acid sequence encoding a CD3z intracellular signaling domain; a nucleic acid sequence encoding a T2A, P2A, E2A, or F2A site; a nucleic acid sequence encoding an antigen-binding domain that binds to CD20; a nucleic acid sequence encoding a CD8 transmembrane domain; a nucleic acid sequence encoding a 4-1BB costimulatory domain; a nucleic acid sequence encoding a CD3z intracellular signaling domain. In other words, the claimed nucleic acid molecule encodes a CD19 CAR comprising a CD28 costimulatory domain and a CD20 CAR comprising a 4-1BB costimulatory domain. Neither of June or Pulé disclose a single nucleic acid molecule encoding a CD19 CAR comprising a CD28 costimulatory domain and a CD20 CAR comprising a 4-1BB costimulatory domain. Claim 17 and its dependencies are therefore non-obvious over June and Pulé for at least this reason and the reasons given above with respect to claims 1 and 10.
Applicant argues that for at least the reasons above, the claims, as amended, are non-obvious over June and Pulé and this rejection may be withdrawn.
Applicant's arguments have been considered, but have not been found persuasive. In response to applicant's argument that the Neither of June nor Pulé teach the specific CAR structures of claim 17, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). June teaches, as previously set forth, that the CARs can have CD3 zeta signaling domains and 4-1BB or CD28 co-stimulatory domains. See ¶¶ 0010, 0038, 0055, 0059, 0337 and Fig. 1A and Table 5. Additionally, Pulé teaches that the activating endodomains of the OR gate” cell can comprise CD3 zeta signaling domains and 4-1BB or CD28 co-stimulatory domains. See ¶¶ 00272-0275. Thus given that CARs that have CD3 zeta signaling domains and 4-1BB or CD28 co-stimulatory domains are well known in the art and taught by June and Pulé, it would have been obvious to constructs the specific CAR structures of claim 17 for optimal CAR activity. Therefore, Applicant’s arguments are not found persuasive and the rejection is 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 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.
5. Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 6-20 of U.S. Patent No. 11,597,754 (June et al. Mar. 7, 2023) in view of US 2013/0287748 A1 (June et al. Oct. 31, 2013, IDS), “June” and in view of US 2016/0296562 A1 (Pulé et al. Oct. 13, 2016, filed Nov. 21, 2014), “Pulé” for the reasons of record set forth below.
The ‘754 claims are drawn to a method of treating a human with cancer, the method comprising: administering to the human a T cell genetically engineered to express a chimeric antigen receptor (CAR), wherein the CAR comprises: (i) an antigen binding domain, wherein the antigen binding domain targets a tumor antigen selected from the group consisting of CD19, CD20, CD22, ROR1, mesothelin, CD33, IL3Ra, c-Met, PSMA, Glycolipid F77, EGFRvIII, GD-2, NY-ESO-1 TCR, MAGE A3 TCR, and MUC1 (CA15-3), and any combination thereof, (ii) a transmembrane domain, (iii) a costimulatory signaling region comprising a CD2 signaling domain and a CD28 signaling domain, or a CD2 signaling domain and a 4-1BB signaling domain, wherein the CD2 signaling domain is encoded by a nucleic acid sequence comprising nucleotides 996-1346 of SEQ ID NO: 1, and (iv) a CD3 zeta signaling domain, thereby treating the human. See claim1
The ‘754 claims teach as set forth above, but do not explicitly teach a population of cells comprising an FMC63 CAR and a CD20 CAR expressed by a first and a second nucleic acid or a nucleic acid encoding F2A.
June and Pulé teach as set forth above.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the ‘754 claims, June and Pulé and express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule separated by an F2A sequence because the ‘754 claims teach that the CARs can bind CD19, CD20 or both antigens, June teaches the FMC63 CAR and that the CAR the antigen binding domain in the CARs can bind CD19, CD20 or both antigens, and Pulé teaches expressing separate CD19 and CD20 CARs separated by an F2A sequence in T-cells and NK cells. One would have been motivated to express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule because Pulé teaches that having the second CAR to CD20 is an advantage because some cancers become CD19 negative after CD19 targeting, so it gives a “back-up” antigen, should this occur.
Response to Arguments
6. Applicant argues that they traverse the rejection for at least the grounds given above with respect to the obviousness rejection.
In addition, Applicant argues that as described in the MPEP § 804.01(II)(B), "[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)". When determining whether a nonstatutory double patenting rejection may be appropriate, the MPEP states that:
the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences. Then the examiner should determine whether those differences render the claims patentably distinct using an anticipation analysis and/or an obviousness analysis.
Applicant argues that regarding an anticipation analysis, the MPEP states that: "[t]he claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by the reference claim(s). Regarding an obviousness analysis, the MPEP states that:
Any nonstatutory double patenting rejection made under the obviousness analysis should make clear:
(A) The differences between the inventions defined by the conflicting claims - a claim in the patent compared to a claim in the application; and
(B) The reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue would have been an obvious variation of the invention defined in a claim in the patent.
Applicant argues that instant claim 1 recites a population of cells comprising: (a) a first chimeric antigen receptor (CAR) molecule comprising an antigen-binding domain which is a CD19 binding domain, wherein the CD19 binding domain comprises a scFv comprising the LC CDR1, LC CDR2, LC CDR3, HC CDR1, HC CDR2, and HC CDR3 of FMC63; and (b) a second CAR comprising an antigen-binding domain which is a CD20 binding domain; wherein the first CAR and the second CAR each comprise an intracellular signaling domain comprising a stimulatory domain and a costimulatory domain. Instant claims 10 and 17 also require a first CAR and a second CAR. On the other hand, claims 1, 2, 4, and 6-20 of U.S. Patent No. 11,597,754 do not recite a first CAR and a second CAR, much less a first CAR molecule comprising an antigen-binding domain which is a CD19 binding domain, wherein the CD19 binding domain comprises a scFv comprising the LC CDR1, LC CDR2, LC CDR3, HC CDR1, HC CDR2, and HC CDR3 of FMC63; and (b) a second CAR comprising an antigen-binding domain which is a CD20 binding domain. For instance, claim 1 of U.S. Patent No. 11,597,754 recites, in pertinent part, "administering to the human a T cell genetically engineered to express a chimeric antigen receptor (CAR)". The differences between instant claim 1 and the reference patent claims, as noted above, render the instant claims patentably distinct from, not anticipated by, and not obvious over the reference patent claims.
Applicant argues that for at least these reasons, claims 1-24 are free of the obviousness-type double patenting rejection over claims 1, 2, 4, and 6-20 of U.S. Patent No. 11,597,754. Reconsideration and withdrawal of the rejection is respectfully requested.
Applicant’s arguments have been considered, but have not been found persuasive.
Regarding the arguments set forth above with respect the 35 USC § 103 rejection, the arguments are not found persuasive for the reason set forth above. Additionally, it is noted that it was not argued that the patented claims anticipated the currently pending claims.
Regarding Applicant’s argument that ‘754 claims do not teach a first and second CAR in the T cell, the ‘754 claims teach the T cells comprise a combination of CARs including a CD19 and CD20 CAR. See claim 1. One would have been motivated to express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule because Pulé teaches that having the second CAR to CD20 is an advantage because some cancers become CD19 negative after CD19 targeting, so it gives a “back-up” antigen, should this occur. Thus, the rejection is maintained for the reasons of record.
6 Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims U.S. Patent Nos set forth below in view of US 2013/0287748 A1 (June et al. Oct. 31, 2013, IDS), “June” and in view of US 2016/0296562 A1 (Pulé et al. Oct. 13, 2016, filed Nov. 21, 2014), “Pulé”.
The following US Patents claim anti-CD19 FMC63 CAR T cells and methods of cancer treatment with the CD19 FMC63 CAR T cells or a combination of anti-CD19 and anti-CD20 CARs T-cells.
Citation
Patent No.
Claims
FMC63 Seq ID
IDS (Y or N)
1.
8,906,682
1-30
20
Y
2.
8,911,993
1-21
20
Y
3.
8,916,381
1-28
20
Y
4.
8,975,071
1-17
20
Y
s5.
9,102,760
1-30
20
Y
6.
9,102,761
1-30
20
Y
7.
9,101,584
1-30
20
Y
8.
9,328,156
1-15
20
N
9.
9,464,140
1-28
20
Y
10.
9,481,728
1-30
20
Y
11.
9,499,629
1-53
20
Y
12.
9,518,123
1-26
20
N
13.
9,540,445
1-30
20
N
14.
10,603,378
1-28
N
N
15
10,829,735
1-28
N
N
16.
11,273,219
1-20
N
N
17.
12,240,884
1-24
N
N
For FMC63 SEQ ID NOs of the patents see Identical Protein Groups – NCBI (Chain D, FMC63 single-chain variable fragment, https://www.ncbi.nlm.nih.gov/ipg/?term=FMC63, downloaded 10/27/2025).
The patented claims teach as set forth above, but do not explicitly teach a population of cells comprising an FMC63 CAR and a CD20 CAR expressed by a first and a second nucleic acid or a nucleic acid encoding F2A.
June and Pulé teach as set forth above.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of the patented claims, June and Pulé and express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule separated by an F2A sequence because the patented claims teach the FMC63 CAR or combinations of CD19 and CD20 CARs, June teaches the FMC63 CAR and that the CAR the antigen binding domain in the CARs can bind CD19, CD20 or both antigens, and Pulé teaches expressing separate CD19 and CD20 CARs separated by an F2A sequence in T-cells and NK cells. One would have been motivated to express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule because Pulé teaches that having the second CAR to CD20 is an advantage because some cancers become CD19 negative after CD19 targeting, so it gives a “back-up” antigen, should this occur.
7. Applicant argues that:
Patent Nos. 8,906,682, 8,911,993, 8,916,381, 8,975,071, 9,102,760, 9,102,761, 9,101,584, 9,328,156, 9,464,140, 9,481,728, 9,499,629, 9,518,123, 9,540,445, 10,603,378, and 11,273,219
Applicant argues as described in the MPEP § 804.01(II)(B) and as noted above, "[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)".
Applicant argues that in contrast to the instant claims, the claims of U.S. Patent Nos. 8,906,682, 8,911,993, 8,916,381, 8,975,071, 9,102,760, 9,102,761, 9,101,584, 9,328,156, 9,464,140, 9,481,728, 9,499,629, 9,518,123, 9,540,445, 10,603,378, and 11,273,219, do not recite a first CAR and a second CAR. The differences between instant claim 1 and the reference patent claims, as noted above, render the instant claims patentably distinct from, not anticipated by, and not obvious over the reference patent claims.
Applicant argues that for at least these reasons, claims 1-24 are free of the obviousness-type double patenting rejection over U.S. Patent Nos. 8,906,682, 8,911,993, 8,916,381, 8,975,071, 9,102,760, 9,102,761, 9,101,584, 9,328,156, 9,464,140, 9,481,728, 9,499,629, 9,518,123, 9,540,445, 10,603,378, and 11,273,219. Reconsideration and withdrawal of the rejection is respectfully requested.
Applicant’s arguments have been considered, but have not been found persuasive.
U.S. Patent Nos. 8,906,682, 8,911,993, 8,916,381, 8,975,071, 9,102,760, 9,102,761, 9,101,584, 9,328,156, 9,464,140, 9,481,728, 9,499,629, 9,518,123, 9,540,445, 10,603,378, and 11,273,219 claim anti-CD19 FMC63 CAR T cells and methods of cancer treatment with the CD19 FMC63 CAR T cells or a combination of anti-CD19 and anti-CD20. Thus, the instant claims would have been obvious June teaches the FMC63 CAR and that the CAR the antigen binding domain in the CARs can bind CD19, CD20 or both antigens, and Pulé teaches expressing separate CD19 and CD20 CARs separated by an F2A sequence in T-cells and NK cells. One would have been motivated to express an FMC63 CAR and a CD20 CAR from a first and a second nucleic acid sequence on a single nucleic acid encoding molecule because Pulé teaches that having the second CAR to CD20 is an advantage because some cancers become CD19 negative after CD19 targeting, so it gives a “back-up” antigen, should this occur. Thus, the rejection is maintained for the reasons of record.
Patent Nos. 10,829,735 and 12,240,884
8. Applicant argues that without acquiescing to the Office's position, Applicants request that the non-statutory double patenting rejection be held in abeyance until the rejections outstanding in the instant application are overcome. At that time, Applicants will consider filing a terminal disclaimer, if appropriate.
Applicant’s arguments have been considered, but have not been found persuasive. The patented claims make the currently pending claims obvious for the reasons of record and no terminal disclaimer has been filed.
Conclusion
9. No claims allowed.
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time
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/Peter J Reddig/
Primary Examiner, Art Unit 1642
Prosecution Insights