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 .
Status of the Claims
1. Claims 1-47 are the original claims filed 6/7/2019. In the Response of 9/10/2019, claims 5, 6, 10, 20, 22, 24, 28, and 29 are amended and claims 2, 7-8, 11-19, 21, 25-26, 30, 32, 35, 39, 41, 43, and 45 are cancelled. In the Response of 4/21/2022, Claims 1, 3, 10, 28, and 31 are amended, and claims 42, 44, 46, and 47 are canceled. In the Response of 11/14/2022, claims 1, 3-6, 10, 20, 27-29, 31, 33, 36-38, and 48 are amended. In the Response of 4/10/2023, claims 1, 4, 9, 10, 20, 24, 29, 34, 36, 37, and 48 are amended and new Claims 50-55 are added. In the Response of 7/25/2023, claims 1, 6, 9, 20, 28, 31, 37, 50-52, and 55 are amended, claim 54 is cancelled, and new claims 56-58 are added. In the Response of 12/19/2023, claims 6, 9, 23, 36, 40, 48, 56, and 57 are amended, claims 3, 4, 37, 38, and 49 are cancelled, and new claims 59-61 are added. In the Response of 4/3/2024, Claims 1, 5, 6, 27, 31, 55, and 59 are amended, and Claim 29 is cancelled. In the Response of 11/1/2024, Claims 1, 5-6, 9, 31, 36, and 58-59 are amended and Claims 48 and 55 are canceled. In the Response of 8/12/2025, no amendments are made to the claims.
Applicant’s election without traverse of BTK inhibitor and ibrutinib in the reply filed on 4/21/2022 is acknowledged. Claims 6, 34 and 59 are withdrawn.
Claims 1, 5-6, 9-10, 20, 22-24, 27-28, 31, 33-34, 36, 40, 50-53, and 56-61 are pending.
Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 are the claims under examination. The Office Action is final.
Priority
2. USAN 16/435,257, filed 06/07/2019, and having 3 RCE-type filing therein, is a Divisional of 14/680,860, filed 04/07/2015, now U.S. Patent # 10357514 and having 2 RCE-type filing therein, 14/680,860 Claims Priority from Provisional Application 62/097,278, filed 12/29/2014, 14/680,860 Claims Priority from Provisional Application 62/087,888, filed 12/05/2014, 14/680,860 Claims Priority from Provisional Application 62/076,238, filed 11/06/2014, 14/680,860 Claims Priority from Provisional Application 62/036,493, filed 08/12/2014, 14/680,860 Claims Priority from Provisional Application 62/007,309, filed 06/03/2014, 14/680,860 Claims Priority from Provisional Application 61/976,396, filed 04/07/2014.
Information Disclosure Statement
3. As of 10/13/2025, a total of fifteen (15) IDS are filed: 9/10/2019; 9/10/2019; 9/10/2019; 9/10/2019; 9/10/2019; 4/21/2022; 11/14/2022; 4/10/2023; 7/25/2023; 12/19/2023; 4/3/2024; 7/2/2024; 11/1/2024; 1/16/2025; and 8/12/2025. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Rejections
Double Patenting
4. The provisional rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/937,759 (reference application) is withdrawn in view of the abandonment in the notice of abandonment on 7/17/2025.
Rejections Maintained
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
4. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 is/are rejected under 35 U.S.C. 103 as being obvious over Porter et al (IDS 1/16/2025; ref #3; Porter 1) or Porter et al (N Engl J Med. 2011 August 25; 365(8): 725–733; Porter 2) as evidenced by the specification and in view of NCT01029366 (12/9/2009), U.S. Patent No. 10221245 (USAN 14/214,728) and WO 2014/018567 (filing date 7/23/202013) is maintained and as evidenced by Rada et al (Oncotarget, 2017, Vol. 8, (No. 63), pp: 106639-106647) .
a) Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-13 of claim 1.
b) Applicants do not dispute the truth of the matter; that R/R CLL patients were used in the clinical trials for the CTL019 therapy.
c) Applicants allege none of the references specifically teach a R/R CLL patient having previously received a BTK inhibitor, namely, ibrutinin.
Response to Arguments
Porter 2 teaches that for one of the R/R CLL patients “Cytogenetic analysis showed that 3 of 15 cells contained a deletion of chromosome 17p, and fluorescence in situ hybridization (FISH) testing showed that 170 of 200 cells had a deletion involving p53 on chromosome 17p.”
CLL patient refractory- or relapsed-response to ibrutinib therapy is described in WO 2014/018567 (filing date 7/23/202013) and associated with gene mutation(s). AS evidenced by Rada et al (PTO 892), Bruton's tyrosine kinase (BTK) gene is associated with p53, with BTK functioning as a positive regulator of p53's activity. The relationship between BTK and p53 is complex and context-dependent, sometimes involving a tumor suppressor role for BTK in solid cancers, even as it promotes survival in B-cell lymphoma. In B-cell malignancies like chronic lymphocytic leukemia (CLL), BTK promotes the survival and proliferation of cancer cells. BTK inhibitors like ibrutinib are effective treatments because they block this pro-survival signaling. However, inhibiting BTK can also dampen the pro-apoptotic p53 pathway, which is an important consideration when using these therapies.
Clinical Trial NCT01029366 teaches the B-cell lymphoma patients receiving the CTL019 cells are resistant or refractory to at least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy; the CTL019 cells exhibit improved engraftment in vivo. Most notably, ‘366 teaches the CLL patients that are defective in deletion of chromosome 17p are at high risk of CLL disease.
Accordingly, the nexus and link between BTK and p53/ chromosome 17p is well established in the art to the extent that the POSA could reasonably select for a patient population that is R/R to treatment with BKT inhibitors.
The combined reference teachings provide the motivation to treat CLL cancers that are relapsed or refractory from previous therapies that include the BTK inhibitor, ibrutinib, with agents that target CLL biomarkers such as CD19 using CAR-T cell therapies that are established at the time of filing in order to bypass the signaling pathways associated with ibrutinib relapse or resistance.
d) Applicants’ allege “technical benefits” are shown in Example 9 in which PBMC samples were collected from CLL patients before ibrutinib treatment, during ibrutinib treatment at cycle 2, day 1, or during ibrutinib treatment at cycle 12, day 1.11 The cells were then transduced with lentiviral vectors containing CD19 CAR and the proliferation rates were assessed. The instant application teaches that "with regard to proliferation rate, PBMCs isolated between or at cycle 2, day 1 and cycle 12, day 1 are preferred for CAR transduction." In particular, FIG. 27 of the application shows that the proliferation rates of CD19 CAR-expressing cells derived from PBMCs collected following initiation of ibrutinib treatment (at cycle 2, day 1 and cycle 12, day 1) were generally higher than those collected prior to ibrutinib treatment. None of the cited publications describe or suggest such efficacy, nor do the cited publications describe or suggest that it is beneficial to administer CAR-expressing cells to a patient that previously received a kinase inhibitor.’
Response to Arguments
None of the claims are drawn to an BTK inhibitor much less ibrutinib being actively administered to the same mammal receiving the anti-CD19 CAR-expressing population of cells. Generic claim 1 is interpreted as the mammal having received the BTK in the past tense where the mammal is previously deemed R/R. None of the claims recite the active administration of ibrutinib to the mammal just prior to the administration of the anti-CD19 CAR-expressing population of cells. There is a discrepancy in the interpretation of the claims and the comments are not applicable to the instant claim scope. Note that claim 60 is recited in the past tense for the amount of ibrutinib being associated with the R/R state of the mammal rather than as an active administration to the mammal in a regimen with the anti-CD19 CAR cell population.
e) Applicants allege Example 8 describes experiments in which cancer cell lines, including an ibrutinib-resistant cancer cell line, JEKO-1, were treated with CART19 cells. Applicants demonstrated through a series of in vitro experiments that treatment of JEKO-1 cells with CART-19 led to degranulation (as measured by percentage of CD107a+ cells), cytokine production (e.g., production of IL-2 and TNF-alpha), cancer cell killing, and CART proliferation. Moreover, Applicants performed in vivo experiments in which mice were injected with MCL cell lines, including the ibrutinib-resistant JEKO-1. As shown in FIG. 19A, treatment with cells expressing CD19 CAR led to decreased tumor burden in the JEKO-1 MCL mouse model. In summary, Applicants demonstrated that CAR therapy is effective as a monotherapy in ibrutinib-resistant cells, indicating the benefits of a CD19 CAR treatment in treating a mammal that has a hematological cancer and is a partial responder, refractory, or relapsed to a kinase inhibitor.
Response to Arguments
None of the claims are drawn to an BTK inhibitor much less ibrutinib being actively administered to the same mammal receiving the anti-CD19 CAR-expressing population of cells. Generic claim 1 is interpreted as the mammal having received the BTK in the past tense where the mammal is previously deemed R/R. None of the claims recite the active administration of ibrutinib to the mammal just prior to the administration of the anti-CD19 CAR-expressing population of cells. There is a discrepancy in the interpretation of the claims and the comments are not applicable to the instant claim scope. Note that claim 60 is recited in the past tense for the amount being associated with the R/R state of the mammal rather than as an active administration to the mammal in a regimen with the anti-CD19 CAR cell population.
Because the POSA could reasonably conclude that a monotherapy is encompassed by generic claim 1, the claims are prima facie obvious for the reasons set forth herein.
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. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11975026 are maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-13 of claim 1. Claims in the reference patent drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
6. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 on the ground of nonstatutory double patenting as being unpatentable over claims claims 1-12 U.S. Patent No. 12344651 (formerly claims 33-49 of copending Application No. 18/617912 (reference application US 20240390492)) is maintained. The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-13 of claim 1. Claims in the reference patent drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
7. The provisional rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 30, 33, 42-43, 49, 53, 59, 61, 63, 65-66, 84, 140, 149-153, and 160-161 of copending Application No. 17/104,983 (reference application US 20210220404) is maintained. The reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-13 of claim 1. Claims in the reference drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims the VH/VL (VHCDR1-3/VLCDR1-3) domains of the CTL019 CAR construct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
8. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10221245 (USAN 14/214,728); 10253086 (USAN 15/094,674); 10273300 (USAN 14/981,142); 10525083 (USAN 15/727,402); 10774388 (USAN 15/517,597); 10829735 (USAN 15/216,036); 10927184 (USAN 16/192,375); 11026976 (USAN 16/664,223); 11149076 (USAN 16/256,731);
The patent references are not afforded safe harbor protection under 35 USC 121 because none shares continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patents drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
NOTE: USPN 11185537 teaches and discloses CTL019 comprising SEQ ID NO: 218.
NOTE: USPN 11192877 teaches and discloses CTL019 comprising SEQ ID NO: 218.
9. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10711282 is maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
10. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-94 of U.S. Patent No. 9573988 is maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
11. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 11028177 is maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
12. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11273219 is maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
13. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10603378 is maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
14. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of 154-55, 57-81 of U.S. Patent No. 12344657 (formerly copending Application No. 17/464,528 (reference application US 20220195010)) is maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 (FMC63 scfv) taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
CTL019 is the name for a complete chimeric antigen receptor (CAR) T-cell therapy, while FMC63 is a component of that therapy: the single-chain variable fragment (scFv)
15. The provisional rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/339,565 (reference application US 20230374105) is maintained.
The reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 (FMC63 scfv) taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference are drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims the VH/VL domains of the CTL019 CAR construct.
CTL019 is the name for a complete chimeric antigen receptor (CAR) T-cell therapy, while FMC63 is a component of that therapy: the single-chain variable fragment (scFv).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
16. The rejection of Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11872249 is maintained.
The patent reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference patent is drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims the VH/VL domains of the CTL019 CAR construct.
17. Claims 1, 5, 9-10, 20, 22-24, 27-28, 31, 33, 36, 40, 50-53, 56-58 and 60-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20240252538) is maintained.
The reference is not afforded safe harbor protection under 35 USC 121 because it shares no continuity nor restriction/ speciation with the instant claims for the instant application. Applicants do not dispute the truth of the matter; that CTL019 (scfv of SEQ ID NO: 771) taught in the reference art corresponds to the instant claimed anti-CD19 CAR molecule comprising the VH/VL CDR-1-3 of claim 1. Claims in the reference are drawn to identical subject matter to the anti-CD19-CAR of the instant claims are not subject to the same restriction/speciation. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims the VH/VL domains of the CTL019 CAR construct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
18. No claims are allowed.
19. 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.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643