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 .
Claims Status
The amendments and remarks filed 07/14/2026 are acknowledged.
Claims 1-9, 24-26, and 29-38 are pending.
Claims 1, 6-9, 24, and 26 are amended.
Claims 29-38 are new.
Claims 1-9, 24-26, and 29-38 are under examination.
Withdrawn
The objection to the specification is withdrawn. Applicant has amended the specification to overcome the objections.
The objection to claim 9 is withdrawn. Applicant has amended the claim to overcome the objection.
The rejections of claims 2-5, 9, and 26 under 35 U.S.C. 112(b) are withdrawn. Applicant has amended the claims to overcome the rejections.
The rejections of claims 1-9 and 24 under 112(a) are withdrawn. Applicant has amended claim 1 to overcome the rejections.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/14/2026 and 08/13/2026 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
The documents lined through on the 07/14/2026 IDS were not considered because they were not attached.
Rejections Maintained
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6-8, and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 6-8, and 24 recite the limitation “about”. Applicant has provided an explicit definition for “about” meaning “being within a statistically meaningful range of a value” [see paragraph 76 of the Specification]. However, the metes and bounds for “about” are dependent on the interpretation of others for determining what is a “meaningful” error range. Given a single value, one person of ordinary skill in the art could determine that the value is acceptably in the error range. Yet, another person of ordinary skill in the art could determine that it is unacceptable, leading to two different interpretations on if the claim infringes with “about.” Therefore, these claims are indefinite.
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.
This rejection has been modified solely to address the claim amendments and newly added claims.
Claims 1-8, 29-30, 32-33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Madduri et al., 2019 (12/22/2025 IDS), in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892).
Regarding claim 1, Madduri teaches JNJ-68284528 (JNJ-4528; ciltacabtagene autoleucel), a chimeric antigen receptor T cell (CAR-T) therapy, administered to subjects as a single infusion at a target range of 0.5-1.0x106 CAR+ T cells/kg to treat refractory multiple myeloma [page 1, paragraphs 1-2].
Note: SEQ ID NO: 17, as claimed in instant claim 1, is termed ciltacabtagene autoleucel (cilta-cel), as disclosed in the instant specification [see paragraph 86], which is also termed JNJ-68284528 and LCAR-B38M as taught by Madduri et al., 2020 (12/22/2025 IDS). Therefore, the CAR taught by Madduri is the same as the claimed CAR of SEQ ID NO: 17.
However, Madduri does not specifically teach that the CAR T cells are administered within about 2.5 hours at a temperature of about 20-25 degrees Celsius.
Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes [page 1].
Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes [page 4]. Rioufol also teaches that the CAR T cells are administered by a nurse in a hematology department [page 4], and that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
ECA teaches that controlled room temperature is 20-25 degrees Celsius [page 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art to have administered the CAR T cells of Madduri within 2.5 hours, as taught by Dana-Farber, and at a temperature of 20-25 degrees Celsius, as taught by Rioufol and ECA. One would have been motivated to have administered the CAR T cells of Madduri within 2.5 hours at a temperature of 20-25 degrees Celsius because Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes, Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes and that the CAR T cells are administered by a nurse in a hematology department, i.e. a controlled temperature environment, and ECA teaches that that controlled room temperature is 20-25 degrees Celsius. Further, there would be a reasonable expectation of success in administering the CAR T cells within 2.5 hours at a temperature of 20-25 degrees Celsius because these are known values of known parameters in the art.
Claims 2-3 and 29 are included in this rejection because Madduri teaches that patients had received a median of 5 prior lines of treatment [page 2, third paragraph].
Claim 4 is included in this rejection because Madduri teaches that the patients were triple refractory to a PI (proteasome inhibitor), IMiD (immunomodulatory drug), and anti-CD38 antibody, thereby indicating that these were prior lines of therapy [page 2, third paragraph].
Claim 5 is included in this rejection because the CAR T cells of Madduri are necessarily autologous T cells, as evidenced by Abebe et al., 2022 (instant PTO-892) that teaches that Cilta-cel (i.e. SEQ ID NO: 17) is an autologous, gene edited CAR T-cell therapy [see Abstract].
Claims 6 and 30 are included in this rejection because Madduri teaches that cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 over 3 days were used as the conditioning regimen (i.e. lymphodepleting chemotherapy regimen), and that the CAR T cells were administered 5-7 days after the start of the conditioning regimen [page 1, second paragraph – page 2, first paragraph].
Claims 7 and 32 are included in this rejection because Rioufol teaches that the CAR T cells are thawed in a 37 +/- 2 degrees Celsius [page 4]. Thus, since Rioufol teaches that the CAR T cells are thawed at the same temperature, then they necessarily would thaw completely in no more than about 15 minutes.
Claims 8, 33, and 35 are included in this rejection because Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab (immunosuppressant) and corticosteroids were administered to treat patients with CRS [page 2, paragraphs 4-5].
Claims 1-9, 29-30, 32-33, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Madduri et al., 2019 (12/22/2025 IDS), in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Le et al., 2018 (04/14/2026 PTO-892).
The teachings of Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that a majority of the patients treated had grade 1-2 CRS, with 1 patient of Grade 3 and 1 patient of Grade 5, and that tocilizumab and corticosteroids were administered to treat patients with CRS.
However, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the CRS comprises pyrexia and that a symptom of HLH or MAS comprises hypotension or multi-organ dysfunction.
Regarding claims 9 and 36, Le teaches that characteristics of CRS include fever, fatigue, headache, encephalopathy, hypotension (symptom of HLH or MAS), tachycardia, coagulopathy, nausea, capillary leak, and multiorgan dysfunction (symptom of HLH or MAS), often occurring after CAR T-cell therapy [page 943, left column, first paragraph of introduction].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically treated CRS after administering the dose of the T cells, as taught by Madduri, Dana-Farber, Rioufol, and ECA, wherein the CRS comprises pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction, as taught by Le. One would have been motivated to have treated CRS comprising pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction because Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS, and Le teaches that a characteristic of CRS includes fever and symptoms of hypotension and multi-organ dysfunction, often occurring after CAR T-cell therapy.
Claims 1-8, 24-26, 29-30, 32-33, 35, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Madduri et al., 2019 (12/22/2025 IDS), in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Kaiser et al., 2021 (04/14/2026 PTO-892).
The teachings of Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that the patients with refractory multiple myeloma had received a median of 5 prior lines of treatment [page 2, third paragraph] and were triple refractory to a PI (proteasome inhibitor), IMiD (immunomodulatory drug), and anti-CD38 antibody, thereby indicating that these were prior lines of therapy [page 2, third paragraph], and Rioufol teaches that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
However, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the composition further comprises an excipient of dimethyl sulfoxide at 5%.
Regarding claims 24-26 and 37-38, Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO (dimethyl sulfoxide) facilitates improved T cells recovery and functionality [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically formulated the composition of JNJ-68284528 CAR T-cells, as taught by Madduri, to comprise 10% HAS and 5% DMSO, as taught by Kaiser. One would have been motivated to have formulated the CAR T-cells in a container (packaged) with 10% HAS and 5% DMSO (i.e. a ciltacabtagene autoleucel suspension) because Rioufol teaches that CAR T-cells are stored in bags or syringes for infusion in cryogenic containers prior to administration and Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO facilitates improved T cells recovery and functionality.
Further regarding claims 25 and 26, the claims do not require any further steps that have not already been taught by the prior art above. The claims simply add the limitation of comprising a drug product label. MPEP 2112.01 (III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Additionally, The Examiner is interpreting the JNJ-68284528 CAR T cells (i.e. SEQ ID NO: 17) as an approved drug product, a limitation of instant claims 25-26, since the drug is administered to patients in order to treat refractory multiple myeloma, as taught by Madduri.
Claims 1-8, 29-33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Madduri et al., 2019 (12/22/2025 IDS), in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35, and further in view of Yanez et al., 2019 (instant PTO-892).
The teachings of Madduri, Dana-Farber, Rioufol, and ECA are above.
However, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach administering a premedication for 30-60 minutes prior to administering to the subject the T cells and wherein the premedication comprises an antipyretic and an antihistamine.
Regarding claims 6 and 31, Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion [page 2, left column, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes, as taught by Yanez, prior to administering to the subject the T cells of Madduri in the method taught by Madduri, Dana-Farber, Rioufol, and ECA. One would have been motivated to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes prior to administering the T cells because Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
Claims 1-8, 29-30, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Madduri et al., 2019 (12/22/2025 IDS), in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Freyer et al., 2020 (instant PTO-892).
The teachings of Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS, and further, that 1 patient had grade 3 and 1 patient with grade 5 [page 2, paragraphs 4-5].
However, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the corticosteroid is dexamethasone or methylprednisolone.
Regarding claim 34, Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS [page 945, left column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered methylprednisolone or dexamethasone, as taught by Freyer, to the patient of Madduri with grade 3 CRS. One would have been motivated to have administered methylprednisolone or dexamethasone as taught by Freyer to the patient of Madduri with grade 3 CRS because Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
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.
This rejection has been modified solely to address the claim amendments and newly added claims.
Copending Application No. 17/540,736 (‘736)
Claims 1-8, 24-26, 29-30, 32-33, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12-13, 19-21, 24-26, 35-36 and 38-39 of copending Application No. 17/540,736 (‘736) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892).
Regarding claim 1 of the instant application, claims 1 and 85 of ‘736 teach a method of treating a subject who has multiple myeloma, comprising administering to the subject a dose of T cells via a single intravenous infusion comprising a chimeric antigen receptor (CAR) comprising the amino acid sequence of SEO ID NO: 17, wherein the dose comprises 0.5 x 106 to 1.0 x 106 of the T cells per kilogram of the mass of the subject, claim 6 teaches that the method comprises administering to the subject a single bag (package) of the T cells, and wherein the T cells are contained in a single cryopreserved bag (i.e. single infusion).
SEQ ID NO: 17 of ‘736 has 100% sequence identity to SEQ ID NO: 17 of the instant claim.
However, ‘736 does not specifically teach that the CAR T cells are administered within about 2.5 hours at a temperature of about 20-25 degrees Celsius.
Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes [page 1].
Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes [page 4]. Rioufol also teaches that the CAR T cells are administered by a nurse in a hematology department [page 4], and that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
ECA teaches that controlled room temperature is 20-25 degrees Celsius [page 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art to have administered the CAR T cells of ‘736 within 2.5 hours, as taught by Dana-Farber, and at a temperature of 20-25 degrees Celsius, as taught by Rioufol and ECA. One would have been motivated to have administered the CAR T cells of ‘736 within 2.5 hours at a temperature of 20-25 degrees Celsius because Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes, Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes and that the CAR T cells are administered by a nurse in a hematology department, i.e. a controlled temperature environment, and ECA teaches that that controlled room temperature is 20-25 degrees Celsius. Further, there would be a reasonable expectation of success in administering the CAR T cells within 2.5 hours at a temperature of 20-25 degrees Celsius because these are known values of known parameters in the art.
Claims 2, 4, and 29 of the instant application are included in this rejection because claim 1 of ‘736 teaches the subject has received prior treatment with at least three prior lines of treatment, and wherein the at least three prior lines of treatment comprise treatment with at least one medicament, and the at least one medicament comprises:
(a) a PI; (b) an IMiD; or (c) an anti-CD38 antibody, or any combination thereof, claim 35 of ‘736 teaches that the subject has relapsed after the at least three lines of treatment, claim 36 of ‘736 teaches that the multiple myeloma is refractory to at least two medicaments following the at least three prior lines of treatment, claim 38 of ‘736 teaches that the multiple myeloma is refractory to at least three medicaments.
Claim 3 of the instant application is included in this rejection because claim 39 of ‘736 teaches that the multiple myeloma is refractory to at least four or five medicaments, thereby indicating that the subject has received four or more prior lines of therapy.
Claim 5 of the instant application is included in this rejection because claim 82 of ‘736 teaches that the T cells are autologous T cells.
Claims 6 and 30 of the instant application is included in this rejection because claim 12 of ‘736 teaches that the method comprises administering to the subject a lymphodepleting regimen prior to administering the T cells, claim 13 of ‘736 teaches that the lymphodepleting regimen comprises: (a) administration of cyclophosphamide; and/or (b) administration of fludarabine.
Claims 7 and 32 of the instant application is included in this rejection because Rioufol teaches that the CAR T cells are thawed in a 37 +/- 2 degrees Celsius [page 4]. Thus, since Rioufol teaches that the CAR T cells are thawed at the same temperature, then they necessarily would thaw completely in no more than about 15 minutes.
Claims 8, 33, and 35 of the instant application is included in this rejection because claim 19 of ‘736 teaches that the method further comprises treating the subject for cytokine release syndrome (CRS) more than 3 days following administering the T cells without significantly reducing expansion in vivo of the T cells, claim 20 of ‘736 teaches that the treating for CRS comprises administering to the subject an IL-6R inhibitor, claim 21 of ‘736 teaches that the IL-6R inhibitor is an antibody, claim 24 teaches that the IL-6R inhibitor is tocilizumab (immunosuppressant).
Claim 24 of the instant application is included in this rejection because claim 32 of ‘746 teaches that the dose of T cells further comprises an excipient comprising dimethylsulfoxide or dextran-40.
Claims 25 and 26 of the instant application are included in this rejection because the claims do not require any further steps that have not already been taught by the teachings above. The claims simply add the limitation of comprising a drug product label. MPEP 2112.01 (III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Additionally, the Examiner is interpreting the CAR T cell of ‘349 as an approved drug product, a limitation of instant claims 25-26, since the drug is administered to patients in order to treat relapsed and/or refractory multiple myeloma.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-30, 32-33, and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12-13, 19-21, 24-26, 35-36 and 38-39 of copending Application No. 17/540,736 (‘736) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 24-26, 29-30, 32-33, and 35 above, and further in view of Le et al., 2018 (04/14/2026 PTO-892).
The teachings of ‘736, Dana-Farber, Rioufol, and ECA are above. To reiterate, claim 19 of ‘736 teaches that the method further comprises treating the subject for cytokine release syndrome (CRS) more than 3 days following administering the T cells without significantly reducing expansion in vivo of the T cells, claim 20 of ‘736 teaches that the treating for CRS comprises administering to the subject an IL-6R inhibitor, claim 21 of ‘736 teaches that the IL-6R inhibitor is an antibody, claim 24 teaches that the IL-6R inhibitor is tocilizumab.
However, ‘736, Dana-Farber, Rioufol, and ECA do not specifically teach that the CRS comprises pyrexia (fever).
Regarding claims 9 and 36, Le teaches that characteristics of CRS include fever, fatigue, headache, encephalopathy, hypotension (symptom of HLH or MAS), tachycardia, coagulopathy, nausea, capillary leak, and multiorgan dysfunction (symptom of HLH or MAS), often occurring after CAR T-cell therapy [page 943, left column, first paragraph of introduction].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically treated CRS after administering the dose of the T cells, as taught by ‘736, Dana-Farber, Rioufol, and ECA, wherein the CRS comprises pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction, as taught by Le. One would have been motivated to have treated CRS comprising pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction because claim 19 of ‘736 teaches that the method further comprises treating the subject for cytokine release syndrome (CRS) more than 3 days following administering the T cells without significantly reducing expansion in vivo of the T cells, claim 20 of ‘736 teaches that the treating for CRS comprises administering to the subject an IL-6R inhibitor, claim 21 of ‘736 teaches that the IL-6R inhibitor is an antibody, claim 24 teaches that the IL-6R inhibitor is tocilizumab, and Le teaches that a characteristic of CRS includes fever and symptoms of hypotension and multi-organ dysfunction, often occurring after CAR T-cell therapy.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 24-26, 29-30, 32-33, 35, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12-13, 19-21, 24-26, 35-36 and 38-39 of copending Application No. 17/540,736 (‘736) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 24-26, 29-30, 32-33, and 35 above, and further in view of Kaiser et al., 2021 (04/14/2026 PTO-892).
The teachings of ‘736, Dana-Farber, Rioufol, and ECA are above.
However, ‘736, Dana-Farber, Rioufol, and ECA do not specifically teach that the composition further comprises an excipient of dimethyl sulfoxide at 5%.
Regarding claims 37-38, Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO (dimethyl sulfoxide) facilitates improved T cells recovery and functionality [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically formulated the composition of T-cells, as taught by ‘736, to comprise 10% HAS and 5% DMSO, as taught by Kaiser. One would have been motivated to have formulated the CAR T-cells in a container (packaged) with 10% HAS and 5% DMSO (i.e. a ciltacabtagene autoleucel suspension) because Rioufol teaches that CAR T-cells are stored in bags or syringes for infusion in cryogenic containers prior to administration and Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO facilitates improved T cells recovery and functionality.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 24-26, 29-33, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12-13, 19-21, 24-26, 35-36 and 38-39 of copending Application No. 17/540,736 (‘736) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 24-26, 29-30, 32-33, and 35 above, and further in view of Yanez et al., 2019 (instant PTO-892).
The teachings of ‘736, Dana-Farber, Rioufol, and ECA are above.
However, ‘736, Dana-Farber, Rioufol, and ECA do not specifically teach administering a premedication for 30-60 minutes prior to administering to the subject the T cells and wherein the premedication comprises an antipyretic and an antihistamine.
Regarding claims 6 and 31, Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion [page 2, left column, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes, as taught by Yanez, prior to administering to the subject the T cells of ‘736 in the method taught by ‘736, Dana-Farber, Rioufol, and ECA. One would have been motivated to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes prior to administering the T cells because Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 24-26, 29-30, 32-33, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 12-13, 19-21, 24-26, 35-36 and 38-39 of copending Application No. 17/540,736 (‘736) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 24-26, 29-30, 32-33, and 35 above, and further in view of Freyer et al., 2020 (instant PTO-892).
The teachings of ‘736, Dana-Farber, Rioufol, and ECA are above.
However, ‘736, Dana-Farber, Rioufol, and ECA do not specifically teach that the corticosteroid is dexamethasone or methylprednisolone.
Regarding claim 34, Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS [page 945, left column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered methylprednisolone or dexamethasone, as taught by Freyer, to the patient of ‘736 with CRS. One would have been motivated to have administered methylprednisolone or dexamethasone as taught by Freyer to the patient of with CRS because Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/052,349 (‘349)
Claims 1-7, 24-26, 29-30, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 104,151,189, 220-221, and 223-224 of copending Application No. 18/052,349 (‘349) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026PTO-892).
Regarding claim 1 of the instant application, claims 1-3 of ‘349 teach a method of treating a subject, said method comprising administering to the subject a composition comprising a therapeutically effective number of T cells comprising a chimeric antigen receptor (CAR), to deliver to the subject a dose of CAR expressing T cells (CAR-T cells), wherein said subject has multiple myeloma, claims 189, 221, and 224 teach that the CAR comprises the amino acid sequence of SEQ ID NO: 17, claims 151, 220, and 223 teaches that the administration of said CAR-T cells is via a single intravenous infusion, wherein the single intravenous infusion is administered using a single bag (package) of CAR-T cells and that the dose comprises 1.0 x 105 to 5.0 x 106 of said CAR-T cells per kilogram of the mass of the subject.
SEQ ID NO: 17 of ‘349 has 100% sequence identity to SEQ ID NO: 17 of the instant claim.
However, ‘349 does not specifically teach that the CAR T cells are administered within about 2.5 hours at a temperature of about 20-25 degrees Celsius.
Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes [page 1].
Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes [page 4]. Rioufol also teaches that the CAR T cells are administered by a nurse in a hematology department [page 4], and that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
ECA teaches that controlled room temperature is 20-25 degrees Celsius [page 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art to have administered the CAR T cells of ‘349 within 2.5 hours, as taught by Dana-Farber, and at a temperature of 20-25 degrees Celsius, as taught by Rioufol and ECA. One would have been motivated to have administered the CAR T cells of ‘349 within 2.5 hours at a temperature of 20-25 degrees Celsius because Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes, Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes and that the CAR T cells are administered by a nurse in a hematology department, i.e. a controlled temperature environment, and ECA teaches that that controlled room temperature is 20-25 degrees Celsius. Further, there would be a reasonable expectation of success in administering the CAR T cells within 2.5 hours at a temperature of 20-25 degrees Celsius because these are known values of known parameters in the art.
Claims 2, 3, and 29 of the instant application are included in this rejection because claim 104 of ‘349 teaches that the subject received prior treatment with at least four prior lines of therapy and the subject has relapsed after said at least one prior line of therapy, claim 151 of ‘349 teaches that the multiple myeloma is refractory to at least four or at least five medicaments, and claim 220 of ‘349 teaches that the multiple myeloma is refractory to at least at least four or at least five medicaments, thereby indicating that the subject has relapsed and/or refractory myeloma.
Claim 4 of the instant application is included in this rejection because claim 104 of ‘349 teaches that the at least four medicaments further comprises a proteasomal inhibitor, an immunomodulatory drug and an anti-CD38 antibody.
Claim 5 of the instant application is included in this rejection because claims 189, 221, and 224 of ‘349 teaches that the T cells are autologous.
Claims 6 and 30 of the instant application are included in this rejection because claim 151, 220, and 223 of ‘349 teaches that a lymphodepleting regimen precedes said administration of CAR-T cells by approximately 5 days to approximately 7 days, further optionally wherein said lymphodepleting regimen is administered intravenously, further optionally wherein said lymphodepleting regimen comprises administration of cyclophosphamide; or administration of fludarabine.
Claims 7 and 32 of the instant application are included in this rejection because Rioufol teaches that the CAR T cells are thawed in a 37 +/- 2 degrees Celsius [page 4]. Thus, since Rioufol teaches that the CAR T cells are thawed at the same temperature, then they necessarily would thaw completely in no more than about 15 minutes.
Claim 24 of the instant application is included in this rejection because claims 151, 220, and 223 of ‘349 teach that the composition comprising CAR-T cells administered to the subject further comprises an excipient selected from dimethylsulfoxide or dextran-40.
Claims 25 and 26 of the instant application are included in this rejection because the claims do not require any further steps that have not already been taught by the teachings above. The claims simply add the limitation of comprising a drug product label. MPEP 2112.01 (III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Additionally, the Examiner is interpreting the CAR T cell of ‘349 as an approved drug product, a limitation of instant claims 25-26, since the drug is administered to patients in order to treat relapsed and/or refractory multiple myeloma.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-30, 32-33, and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 104,151,189, 220-221, and 223-224 of copending Application No. 18/052,349 (‘349) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-7, 24-26, 29-30, and 32 above, and further in view of Le et al., 2018 (04/14/2026 PTO-892).
The teachings of ‘349, Dana-Farber, Rioufol, and ECA are above.
However, ‘349, Dana-Farber, Rioufol, and ECA do not specifically teach that the CRS comprises pyrexia (fever).
Regarding claims 8, 9, 33, and 35-36 of the instant application, Le teaches that tocilizumab (immunosuppressant) is for the treatment of CAR T-cell-induced CRS [see Abstract] and characteristics of CRS include fever, fatigue, headache, encephalopathy, hypotension (symptom of HLH or MAS), tachycardia, coagulopathy, nausea, capillary leak, and multiorgan dysfunction (symptom of HLH or MAS), often occurring after CAR T-cell therapy [page 943, left column, first paragraph of introduction].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically treated CRS after administering the dose of the T cells, as taught by ‘349, Dana-Farber, Rioufol, and ECA, by administering tocilizumab and wherein the CRS comprises pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction, as taught by Le. One would have been motivated to have treated CRS with tocilizumab wherein the CRS comprises pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction because Le teaches that a characteristic of CRS includes fever and symptoms of hypotension and multi-organ dysfunction often occurs after CAR T-cell therapy and that tocilizumab is for the treatment of CAR T-cell-induced CRS.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 24-26, and 29-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 104,151,189, 220-221, and 223-224 of copending Application No. 18/052,349 (‘349) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-7, 24-26, 29-30, and 32 above, and further in view of Yanez et al., 2019 (instant PTO-892).
The teachings of ‘349, Dana-Farber, Rioufol, and ECA are above.
However, ‘349, Dana-Farber, Rioufol, and ECA do not specifically teach administering a premedication for 30-60 minutes prior to administering to the subject the T cells and wherein the premedication comprises an antipyretic and an antihistamine.
Regarding claims 6 and 31, Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion [page 2, left column, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes, as taught by Yanez, prior to administering to the subject the T cells of ‘349 in the method taught by ‘349, Dana-Farber, Rioufol, and ECA. One would have been motivated to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes prior to administering the T cells because Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-30, and 32-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 104,151,189, 220-221, and 223-224 of copending Application No. 18/052,349 (‘349) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-7, 24-26, 29-30, and 32 above, and Le et al., 2018 (04/14/2026 PTO-892), as applied to claims 8, 9, 33, and 35-36 above, and further in view of Freyer et al., 2020 (instant PTO-892).
The teachings of ‘349, Dana-Farber, Rioufol, ECA, and Le are above.
However, ‘349, Dana-Farber, Rioufol, ECA, and Le do not specifically teach that the corticosteroid is dexamethasone or methylprednisolone.
Regarding claim 34, Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS [page 945, left column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered methylprednisolone or dexamethasone, as taught by Freyer, to the patient of Le with CRS. One would have been motivated to have administered methylprednisolone or dexamethasone as taught by Freyer to the patient with CRS because Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 24-26, 29-30, 32, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 104,151,189, 220-221, and 223-224 of copending Application No. 18/052,349 (‘349) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-7, 24-26, 29-30, and 32 above, and further in view of Kaiser et al., 2021 (04/14/2026 PTO-892).
The teachings of ‘349, Dana-Farber, Rioufol, and ECA are above.
However, ‘349, Dana-Farber, Rioufol, and ECA do not specifically teach that the composition further comprises an excipient of dimethyl sulfoxide at 5%.
Regarding claims 37-38, Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO (dimethyl sulfoxide) facilitates improved T cells recovery and functionality [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically formulated the composition of CAR T-cells, as taught by ‘349 to comprise 10% HAS and 5% DMSO, as taught by Kaiser. One would have been motivated to have formulated the CAR T-cells in a container (packaged) with 10% HAS and 5% DMSO (i.e. a ciltacabtagene autoleucel suspension) because Rioufol teaches that CAR T-cells are stored in bags or syringes for infusion in cryogenic containers prior to administration and Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO facilitates improved T cells recovery and functionality.
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 18/592,234 (‘234)
Claims 1-9, 24-26, 29-30, 32-33, 35, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 23, 26, 34, 37, and 40 of copending Application No. 18/592,234 (‘234) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892).
Regarding claims 1-2 and 29 of the instant application, claim 1 of ‘234 teaches a method of treating a subject, comprising administering to the subject a dose of T cells comprising a chimeric antigen receptor (CAR), wherein the subject has multiple myeloma, has received one to three prior lines of therapies, including a therapy with an immunomodulatory drug (IMiD), and is refractory to the IMiD (i.e. refractory multiple myeloma), claim 26 of ‘234 teaches that the dose of T cells is 0.5-1.0 x 106 cells/kg and that the dose is administered in a single infusion, and claim 40 of ‘234 teaches that the CAR comprises the amino acid sequence of SEQ ID NO: 17.
SEQ ID NO: 17 of ‘234 has 100% sequence identity to SEQ ID NO: 17 of the instant claim.
However, ‘234 does not specifically teach that the CAR T cells are administered within about 2.5 hours at a temperature of about 20-25 degrees Celsius.
Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes [page 1].
Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes [page 4]. Rioufol also teaches that the CAR T cells are administered by a nurse in a hematology department [page 4], and that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
ECA teaches that controlled room temperature is 20-25 degrees Celsius [page 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art to have administered the CAR T cells of ‘234 within 2.5 hours, as taught by Dana-Farber, and at a temperature of 20-25 degrees Celsius, as taught by Rioufol and ECA. One would have been motivated to have administered the CAR T cells of ‘234 within 2.5 hours at a temperature of 20-25 degrees Celsius because Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes, Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes and that the CAR T cells are administered by a nurse in a hematology department, i.e. a controlled temperature environment, and ECA teaches that that controlled room temperature is 20-25 degrees Celsius. Further, there would be a reasonable expectation of success in administering the CAR T cells within 2.5 hours at a temperature of 20-25 degrees Celsius because these are known values of known parameters in the art.
Claim 4 of the instant application is included in this rejection because claim 1 of ‘234 teaches that the subject has received prior therapy of an immunomodulatory drug (IMiD) and claim 17 of ‘234 teaches that the prior therapy further comprises treatment with an anti-CD38 antibody and a proteasome inhibitor.
Claim 5 of the instant application is included in this rejection because the CAR T cells of ‘234 are necessarily autologous T cells, as evidenced by Abebe et al., 2022 (instant PTO-892) that teaches that Cilta-cel (i.e. SEQ ID NO: 17) is an autologous, gene edited CAR T-cell therapy [see Abstract].
Claims 6 and 30 of the instant application are included in this rejection because claim 23 of ‘234 teaches that the patient has received a lymphodepletion therapy, wherein the lymphodepletion therapy comprises cyclophosphamide and/or fludarabine, and claim 26 of ‘234 teaches that the T cells are administered after the start of lymphodepletion therapy.
Claims 7 and 32 of the instant application are included in this rejection because Rioufol teaches that the CAR T cells are thawed in a 37 +/- 2 degrees Celsius [page 4]. Thus, since Rioufol teaches that the CAR T cells are thawed at the same temperature, then they necessarily would thaw completely in no more than about 15 minutes.
Claims 8, 9, 33, and 35 of the instant application are included in this rejection because claim 37 of ‘234 teaches that the subject is further treated for a CAR-T-associated adverse event after administering the dose of the T cells, wherein the adverse event is CRS, and the treatment comprises tocilizumab (immunosuppressant), and claim 34 of ‘234 teaches that the adverse event comprises pyrexia.
Claims 24, 37, and 38 of the instant application are included in this rejection because claim 40 of ‘234 teaches that the dose of T cells is formulated in a composition comprising 5% dimethyl sulfoxide (DMSO).
Claims 25 and 26 of the instant application are included in this rejection because the claims do not require any further steps that have not already been taught by the teachings above. The claims simply add the limitation of comprising a drug product label. MPEP 2112.01 (III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Additionally, the Examiner is interpreting the CAR T cell of ‘234 as an approved drug product, a limitation of instant claims 25-26, since the drug is administered to patients in order to treat refractory multiple myeloma.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-33, 35, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 23, 26, 34, 37, and 40 of copending Application No. 18/592,234 (‘234) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-9, 24-26, 29-30, 32-33, 35, and 37-38 above, and further in view of Yanez et al., 2019 (instant PTO-892).
The teachings of ‘234, Dana-Farber, Rioufol, and ECA are above.
However, ‘234, Dana-Farber, Rioufol, and ECA do not specifically teach administering a premedication for 30-60 minutes prior to administering to the subject the T cells and wherein the premedication comprises an antipyretic and an antihistamine.
Regarding claims 6 and 31, Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion [page 2, left column, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes, as taught by Yanez, prior to administering to the subject the T cells of ‘234 in the method taught by ‘234, Dana-Farber, Rioufol, and ECA. One would have been motivated to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes prior to administering the T cells because Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-30, 32-35, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 23, 26, 34, 37, and 40 of copending Application No. 18/592,234 (‘234) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-9, 24-26, 29-30, 32-33, 35, and 37-38 above, and further in view of Freyer et al., 2020 (instant PTO-892).
The teachings of ‘234, Dana-Farber, Rioufol, and ECA are above.
However, ‘234, Dana-Farber, Rioufol, and ECA do not specifically teach that the corticosteroid is dexamethasone or methylprednisolone.
Regarding claim 34, Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS [page 945, left column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered methylprednisolone or dexamethasone, as taught by Freyer, to the patient of ‘234 with CRS. One would have been motivated to have administered methylprednisolone or dexamethasone as taught by Freyer to the patient of with CRS because Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-30, 32-33, and 35-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 23, 26, 34, 37, and 40 of copending Application No. 18/592,234 (‘234) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-9, 24-26, 29-30, 32-33, 35, and 37-38 above, and further in view of Le et al., 2018 (04/14/2026 PTO-892).
The teachings of ‘234, Dana-Farber, Rioufol, and ECA are above.
However, ‘234, Dana-Farber, Rioufol, and ECA do not specifically teach that the CRS comprises a symptom of HLH or MAS which comprises hypotension or multi-organ dysfunction.
Regarding claim 36, Le teaches that characteristics of CRS include fever, fatigue, headache, encephalopathy, hypotension (symptom of HLH or MAS), tachycardia, coagulopathy, nausea, capillary leak, and multiorgan dysfunction (symptom of HLH or MAS), often occurring after CAR T-cell therapy [page 943, left column, first paragraph of introduction].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically treated CRS after administering the dose of the T cells, as taught by ‘234, Dana-Farber, Rioufol, and ECA, wherein the CRS comprises pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction, as taught by Le. One would have been motivated to have treated CRS comprising pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction because ‘234 teaches administering tocilizumab to treat CRS, and Le teaches that a characteristic of CRS includes fever and symptoms of hypotension and multi-organ dysfunction, often occurring after CAR T-cell therapy.
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 19/045,247 (‘247)
Claims 1-9, 24-26, 29-30, 32-33, 35, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 31, 39, 86, 88, 95-96, 99, 116-117, and 119 of copending Application No. 19/045,247 (‘247) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892).
Regarding claims 1-2 of the instant application, claim 1 of ‘247 teaches a method of treating a subject with multiple myeloma, the method comprising administering to the subject a dose of T cells comprising a chimeric antigen receptor (CAR), claim 39 of ‘247 teaches that the dose of T cells is in a single infusion, claim 116 of ‘247 teaches that the CAR comprises the amino acid sequence of SEQ ID NO: 17, and claim 119 of ‘247 teaches a method of treating a subject with multiple myeloma, wherein the subject has not achieved a complete response after receiving an initial therapy comprising (1) 4 to 8 cycles of an induction therapy, (2) a high-dose chemotherapy, and (3) an autologous stem cell transplantation (ASCT) (i.e. refractory), the method comprising administering to the subject a dose of T cells comprising a chimeric antigen receptor (CAR) comprising the amino acid sequence of SEQ ID NO: 17.
SEQ ID NO: 17 of ‘247 has 100% sequence identity to SEQ ID NO: 17 of the instant claim.
However, ‘247 does not specifically teach that the CAR T cells are administered within about 2.5 hours at a temperature of about 20-25 degrees Celsius.
Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes [page 1].
Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes [page 4]. Rioufol also teaches that the CAR T cells are administered by a nurse in a hematology department [page 4], and that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
ECA teaches that controlled room temperature is 20-25 degrees Celsius [page 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art to have administered the CAR T cells of ‘247 within 2.5 hours, as taught by Dana-Farber, and at a temperature of 20-25 degrees Celsius, as taught by Rioufol and ECA. One would have been motivated to have administered the CAR T cells of ‘247 within 2.5 hours at a temperature of 20-25 degrees Celsius because Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes, Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes and that the CAR T cells are administered by a nurse in a hematology department, i.e. a controlled temperature environment, and ECA teaches that that controlled room temperature is 20-25 degrees Celsius. Further, there would be a reasonable expectation of success in administering the CAR T cells within 2.5 hours at a temperature of 20-25 degrees Celsius because these are known values of known parameters in the art.
Claims 3-4 and 29 of the instant application are included in this rejection because claim 2 of ‘247 teaches that the initial (prior) therapy further comprises 4 to 8 cycles of an induction therapy, wherein the induction therapy comprises a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and further comprises an anti-CD38 antibody.
Claim 5 of the instant application is included in this rejection because the CAR T cells of ‘247 are necessarily autologous T cells, as evidenced by Abebe et al., 2022 (instant PTO-892) that teaches that Cilta-cel (i.e. SEQ ID NO: 17) is an autologous, gene edited CAR T-cell therapy [see Abstract].
Claims 6 and 30 of the instant application are included in this rejection because claim 31 of ‘247 teaches that the subject has further received a lymphodepletion therapy at least about 5 to about 7 days prior to the administering of the dose of the T cells, wherein the lymphodepletion therapy comprises administering cyclophosphamide and fludarabine.
Claims 7 and 32 of the instant application are included in this rejection because Rioufol teaches that the CAR T cells are thawed in a 37 +/- 2 degrees Celsius [page 4]. Thus, since Rioufol teaches that the CAR T cells are thawed at the same temperature, then they necessarily would thaw completely in no more than about 15 minutes.
Claims 8-9, 33, and 35 of the instant application are included in this rejection because claim 86 of ‘247 teaches that the method further comprises treating the subject for an adverse event after the administering of the dose of the T cells, claim 88 of ‘247 teaches that the adverse event comprises a treatment-emergent adverse event, claim 96 teaches that the treatment emergent adverse event is CRS, claim 99 of ‘247 teaches that treatment for the CRS comprises tocilizumab, and claim 95 of ‘247 teaches that the treatment-emergent adverse event comprises pyrexia.
Claims 24, 37, and 38 of the instant application are included in this rejection because claim 117 of ‘247 teaches that the dose of T cells is formulated in a composition comprising 5% dimethyl sulfoxide (DMSO).
Claims 25 and 26 of the instant application are included in this rejection because the claims do not require any further steps that have not already been taught by the teachings above. The claims simply add the limitation of comprising a drug product label. MPEP 2112.01 (III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Additionally, the Examiner is interpreting the CAR T cell of ‘247 as an approved drug product, a limitation of instant claims 25-26, since the drug is administered to patients in order to treat refractory multiple myeloma.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-33, 35, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 31, 39, 86, 88, 95-96, 99, 116-117, and 119 of copending Application No. 19/045,247 (‘247) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-9, 24-26, 29-30, 32-33, 35, and 37-38 above, and further in view of Yanez et al., 2019 (instant PTO-892).
The teachings of ‘247, Dana-Farber, Roufol, and ECA are above.
However, ‘247, Dana-Farber, Roufol, and ECA do not specifically teach administering a premedication for 30-60 minutes prior to administering to the subject the T cells and wherein the premedication comprises an antipyretic and an antihistamine.
Regarding claims 6 and 31, Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion [page 2, left column, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes, as taught by Yanez, prior to administering to the subject the T cells of ‘247 in the method taught by ‘247, Dana-Farber, Roufol, and ECA. One would have been motivated to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes prior to administering the T cells because Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 24-26, 29-30, 32-33, and 35-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 31, 39, 86, 88, 95-96, 99, 116-117, and 119 of copending Application No. 19/045,247 (‘247) in view of Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-9, 24-26, 29-30, 32-33, 35, and 37-38 above, and further in view of Le et al., 2018 (04/14/2026 PTO-892).
The teachings of ‘247, Dana-Farber, Roufol, and ECA are above.
However, ‘247, Dana-Farber, Roufol, and ECA do not specifically teach that the CRS comprises a symptom of HLH or MAS comprises hypotension or multi-organ dysfunction.
Le teaches that characteristics of CRS include fever, fatigue, headache, encephalopathy, hypotension (symptom of HLH or MAS), tachycardia, coagulopathy, nausea, capillary leak, and multiorgan dysfunction (symptom of HLH or MAS), often occurring after CAR T-cell therapy [page 943, left column, first paragraph of introduction].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically treated CRS after administering the dose of the T cells, as taught by ‘247, Dana-Farber, Roufol, and ECA, wherein the CRS comprises symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction, as taught by Le. One would have been motivated to have treated CRS comprising symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction because ‘247 teaches treating CRS, and Le teaches that a characteristic of CRS includes fever and symptoms of hypotension and multi-organ dysfunction, often occurring after CAR T-cell therapy.
This is a provisional nonstatutory double patenting rejection.
Copending Application No. 19/076,517 (‘517)
Claims 1-8, 29-30, 32-33, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13, 16-17, and 21 of copending Application No. 19/076,517 (‘517) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026PTO-892).
Regarding claims 1-2 of the instant application, claims 1-3 of ‘517 teach a method of treating a multiple myeloma in a subject in need thereof, the method comprising administering ciltacabtagene autoleucel to the subject, wherein the subject has received one, two, or three prior lines of therapy, wherein at least one of the prior lines of therapy comprise treatment with an immunomodulatory drug (IMiD), and the subject is refractory to the IMiD, claim 17 of ‘517 teaches that the ciltacabtagene autoleucel is administered to the subject at a dose of about 0.5 to about 1.0 x 106 CAR-positive viable T cells/kg.
Note: SEQ ID NO: 17, as claimed in instant claim 1, is termed ciltacabtagene autoleucel (cilta-cel), as disclosed in the instant specification [see paragraph 86]. Therefore, the ciltacabtagene autoleucel taught by ‘517 is the same as the claimed CAR of SEQ ID NO: 17.
However, ‘517 does not specifically teach that the CAR T cells are administered in a single infusion and within about 2.5 hours at a temperature of about 20-25 degrees Celsius.
Madduri teaches JNJ-68284528 (JNJ-4528; ciltacabtagene autoleucel), a chimeric antigen receptor T cell (CAR-T) therapy, administered to subjects as a single infusion at a target range of 0.5-1.0x106 CAR+ T cells/kg to treat refractory multiple myeloma [page 1, paragraphs 1-2].
Note: SEQ ID NO: 17, as claimed in instant claim 1, is termed ciltacabtagene autoleucel (cilta-cel), as disclosed in the instant specification [see paragraph 86], which is also termed JNJ-68284528 and LCAR-B38M as taught by Madduri et al., 2020 (12/22/2025 IDS). Therefore, the CAR taught by Madduri above is the same as the claimed CAR of SEQ ID NO: 17.
Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes [page 1].
Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes [page 4]. Rioufol also teaches that the CAR T cells are administered by a nurse in a hematology department [page 4], and that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
ECA teaches that controlled room temperature is 20-25 degrees Celsius [page 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art to have administered the CAR T cells of ‘517 in a single infusion, as taught by Madduri. One would have been motivated to have administered the CAR T cells of ‘517 in a single infusion because Madduri teaches doing so with an identical CAR T cell, and therefore, there would be a reasonable expectation of success because this is a known parameter in the art.
It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to one of ordinary skill in the art to have administered the CAR T cells of ‘517 within 2.5 hours, as taught by Dana-Farber, and at a temperature of 20-25 degrees Celsius, as taught by Rioufol and ECA. One would have been motivated to have administered the CAR T cells of ‘517 within 2.5 hours at a temperature of 20-25 degrees Celsius because Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes, Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes and that the CAR T cells are administered by a nurse in a hematology department, i.e. a controlled temperature environment, and ECA teaches that that controlled room temperature is 20-25 degrees Celsius. Further, there would be a reasonable expectation of success in administering the CAR T cells within 2.5 hours at a temperature of 20-25 degrees Celsius because these are known values of known parameters in the art.
Claims 3 and 29 of the instant application are included in this rejection because Madduri teaches that patients had received a median of 5 prior lines of treatment [page 2, third paragraph].
Claim 4 of the instant application is included in this rejection because claim 1 of ‘517 teaches that the subject had at a prior line of therapy comprising an IMiD, claim 13 of ‘517 teaches that the prior lines of therapy further comprise a proteasome inhibitor, and claim 16 of ‘517 teaches that the prior lines of therapy further comprise treatment with an anti-CD38 antibody.
Claim 5 of the instant application is included in this rejection because the CAR T cells of ‘517 are necessarily autologous T cells, as evidenced by Abebe et al., 2022 (instant PTO-892) that teaches that Cilta-cel (i.e. SEQ ID NO: 17) is an autologous, gene edited CAR T-cell therapy [see Abstract].
Claims 6 and 30 of the instant application is included in this rejection because claim 21 of ‘517 teaches that the subject has further received a lymphodepletion therapy, wherein the lymphodepletion therapy comprises cyclophosphamide and/or fludarabine, and Madduri teaches that cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 over 3 days were used as the conditioning regimen (i.e. lymphodepleting chemotherapy regimen), and that the CAR T cells were administered 5-7 days after the start of the conditioning regimen [page 1, second paragraph – page 2, first paragraph].
Claims 7 and 32 are included in this rejection because Rioufol teaches that the CAR T cells are thawed in a 37 +/- 2 degrees Celsius [page 4]. Thus, since Rioufol teaches that the CAR T cells are thawed at the same temperature, then they necessarily would thaw completely in no more than about 15 minutes.
Claims 8, 33, and 35 are included in this rejection because Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab (immunosuppressant) and corticosteroids were administered to treat patients with CRS [page 2 , paragraphs 4-5].
This is a provisional nonstatutory double patenting rejection.
Claims 1-9, 29-30, 32-33, and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13, 16-17, and 21 of copending Application No. 19/076,517 (‘517) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Le et al., 2018 (04/14/2026 PTO-892).
The teachings of ‘517, Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS.
However, ‘517, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the CRS comprises pyrexia (fever) and that a symptom of HLH or MAS comprises hypotension or multi-organ dysfunction.
Regarding claims 9 and 36, Le teaches that characteristics of CRS include fever, fatigue, headache, encephalopathy, hypotension (symptom of HLH or MAS), tachycardia, coagulopathy, nausea, capillary leak, and multiorgan dysfunction (symptom of HLH or MAS), often occurring after CAR T-cell therapy [page 943, left column, first paragraph of introduction].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically treated CRS after administering the dose of the T cells, as taught by ‘517, Madduri, Dana-Farber, Rioufol, and ECA, wherein the CRS comprises pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction, as taught by Le. One would have been motivated to have treated CRS comprising pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction because Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS, and Le teaches that a characteristic of CRS includes fever, often occurring after CAR T-cell therapy.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 24-26, 29-30, 32-33, 35, and 37-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13, 16-17, and 21 of copending Application No. 19/076,517 (‘517) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Kaiser et al., 2021 (04/14/2026 PTO-892).
The teachings of ‘517, Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Rioufol teaches that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
However, ‘517, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the composition further comprises an excipient of dimethyl sulfoxide at 5%.
Regarding claims 24-26 and 37-38, Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO (dimethyl sulfoxide) facilitates improved T cells recovery and functionality [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically formulated the composition of ciltacabtagene autoleucel (i.e. SEQ ID NO: 17), as taught by ‘517, Madduri, Dana-Farber, Rioufol, and ECA to comprise 10% HAS and 5% DMSO, as taught by Kaiser. One would have been motivated to have formulated the CAR T-cells in a container (packaged) with 10% HAS and 5% DMSO (i.e. a ciltacabtagene autoleucel suspension) because Rioufol teaches that CAR T-cells are stored in bags or syringes for infusion in cryogenic containers prior to administration and Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO facilitates improved T cells recovery and functionality.
Claims 25 and 26 of the instant application are included in this rejection because the claims do not require any further steps that have not already been taught by the teachings above. The claims simply add the limitation of comprising a drug product label. MPEP 2112.01 (III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Additionally, the Examiner is interpreting the ciltacabtagene autoleucel of ‘517 and Madduri as an approved drug product, a limitation of instant claims 25-26, since the drug is administered to patients in order to treat refractory multiple myeloma.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 29-33, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13, 16-17, and 21 of copending Application No. 19/076,517 (‘517) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Yanez et al., 2019 (instant PTO-892).
The teachings of ‘517, Madduri, Dana-Farber, Rioufol, and ECA are above.
However, ‘517, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach administering a premedication for 30-60 minutes prior to administering to the subject the T cells and wherein the premedication comprises an antipyretic and an antihistamine.
Regarding claims 6 and 31, Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion [page 2, left column, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes, as taught by Yanez, prior to administering to the subject the T cells of Madduri in the method taught by ‘517, Madduri, Dana-Farber, Rioufol, and ECA. One would have been motivated to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes prior to administering the T cells because Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
Claims 1-8, 29-30, and 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 13, 16-17, and 21 of copending Application No. 19/076,517 (‘517) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Freyer et al., 2020 (instant PTO-892).
The teachings of ‘517, Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS, and further, that 1 patient had grade 3 and 1 patient with grade 5 [page 2, paragraphs 4-5].
However, ‘517, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the corticosteroid is dexamethasone or methylprednisolone.
Regarding claim 34, Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS [page 945, left column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered methylprednisolone or dexamethasone, as taught by Freyer, to the patient of Madduri with grade 3 CRS. One would have been motivated to have administered methylprednisolone or dexamethasone as taught by Freyer to the patient of Madduri with grade 3 CRS because Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
This is a provisional nonstatutory double patenting rejection.
U.S. Patent No. 10,934,363 (‘363)
Claims 1-8, 29-30, 32-33, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 10-12 of U.S. Patent No. 10,934,363 (‘363) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026PTO-892), and ECA, 2017 (04/14/2026 PTO-892).
Regarding claims 1 of the instant application, claim 1 of ‘363 teaches a chimeric antigen receptor (CAR), claim 7 of ‘363 teaches that the CAR comprises the amino acid sequence of SEQ ID NO: 265, claim 10 of ‘363 teaches an engineered immune effector cells comprising the CAR of claim 1, claim 11 of ‘363 teaches an engineered immune effector cell according to claim 10, wherein the immune effector cell is a T cell, claim 12 of ‘363 teaches a pharmaceutical composition, comprising the engineered immune effector cell of claim 11, and a pharmaceutically acceptable carrier.
SEQ ID NO: 265 of ‘363 has 100% sequence identity to SEQ ID NO: 17 of the instant claim.
However, ‘363 does not teach a method of treating a subject with relapsed or refractory multiple myeloma with the composition comprising the T cells comprising the CAR, that wherein the dose comprises 0.5 x 106 to 1.0 x 106 of the T cells /kg of body weight of the subject, or wherein the method comprises completing administering to the subject the dose of T cells within about 2.5 hours at a temperature of about 20°C to 25°C.
Madduri teaches JNJ-68284528 (JNJ-4528; ciltacabtagene autoleucel), a chimeric antigen receptor T cell (CAR-T) therapy, administered to subjects as a single infusion at a target range of 0.5-1.0x106 CAR+ T cells/kg to treat refractory multiple myeloma [page 1, paragraphs 1-2].
Note: SEQ ID NO: 17, as claimed in instant claim 1, is termed ciltacabtagene autoleucel (cilta-cel), as disclosed in the instant specification [see paragraph 86], which is also termed JNJ-68284528 and LCAR-B38M as taught by Madduri et al., 2020 (12/22/2025 IDS). Therefore, the CAR taught by Madduri is the same as the claimed CAR of SEQ ID NO: 17 and the CAR of SEQ ID NO: 265 of ‘363.
Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes [page 1].
Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes [page 4]. Rioufol also teaches that the CAR T cells are administered by a nurse in a hematology department [page 4] and that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
ECA teaches that controlled room temperature is 20-25 degrees Celsius [page 2].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the CAR T cells of ‘363 to treat the subject with refractory multiple myeloma of Madduri in a single infusion at a dose of 0.5 x 106 to 1.0 x 106 of the T cells /kg of body weight, as taught by Madduri. One would have been motivated to administer the CAR T cells of ‘363 to treat a subject with refractory multiple myeloma, because Madduri teaches administering an identical CAR T cell in a single infusion at a dose of 0.5 x 106 to 1.0 x 106 of the T cells/kg of body weight to treat refractory multiple myeloma. Therefore, there would be a reasonable expectation of success in administering the CAR T cells of ‘363 to treat refractory multiple myeloma because it is a known treatment method in the art.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the CAR T cells of ‘363 within 2.5 hours, as taught by Dana-Farber, and at a temperature of 20-25 degrees Celsius, as taught by Rioufol and ECA. One would have been motivated to have administered the CAR T cells of ‘363 within 2.5 hours at a temperature of 20-25 degrees Celsius because Dana-Farber teaches that CAR T cell infusion takes up to 30 minutes, Rioufol teaches that CAR T cells are thawed to room temperature before administration and are stable for 30 to 90 minutes and that the CAR T cells are administered by a nurse in a hematology department, i.e. a controlled temperature environment, and ECA teaches that that controlled room temperature is 20-25 degrees Celsius. Further, there would be a reasonable expectation of success in administering the CAR T cells within 2.5 hours at a temperature of 20-25 degrees Celsius because these are known values of known parameters in the art.
Claims 2-3 and 29 are included in this rejection because Madduri teaches that patients had received a median of 5 prior lines of treatment [page 2, third paragraph].
Claim 4 is included in this rejection because Madduri teaches that the patients were triple refractory to a PI (proteasome inhibitor), IMiD (immunomodulatory drug), and anti-CD38 antibody, thereby indicating that these were prior lines of therapy [page 2, third paragraph].
Claim 5 is included in this rejection because the CAR T cells of ‘363 are necessarily autologous T cells, as evidenced by Abebe et al., 2022 (instant PTO-892) that teaches that Cilta-cel (i.e. SEQ ID NO: 17) is an autologous, gene edited CAR T-cell therapy [see Abstract].
Claims 6 and 30 are included in this rejection because Madduri teaches that cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 over 3 days were used as the conditioning regimen (i.e. lymphodepleting chemotherapy regimen), and that the CAR T cells were administered 5-7 days after the start of the conditioning regimen [page 1, second paragraph – page 2, first paragraph].
Claims 7 and 32 are included in this rejection because Rioufol teaches that the CAR T cells are thawed in a 37 +/- 2 degrees Celsius [page 4]. Thus, since Rioufol teaches that the CAR T cells are thawed at the same temperature, then they necessarily would thaw completely in no more than about 15 minutes.
Claims 8, 33, and 35 are included in this rejection because Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS [page 2 , paragraphs 4-5].
Claims 1-9, 29-30, 32-33, and 35-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 10-12 of U.S. Patent No. 10,934,363 (‘363) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Le et al., 2018 (04/14/2026 PTO-892).
The teachings of ‘363, Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS.
However, ‘363, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the CRS comprises pyrexia (fever).
Regarding claims 9 and 36, Le teaches that characteristics of CRS include fever, fatigue, headache, encephalopathy, hypotension (symptom of HLH or MAS), tachycardia, coagulopathy, nausea, capillary leak, and multiorgan dysfunction (symptom of HLH or MAS), often occurring after CAR T-cell therapy [page 943, left column, first paragraph of introduction].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically treated CRS after administering the dose of the T cells, as taught by ‘363, Madduri, Dana-Farber, Rioufol, and ECA, wherein the CRS comprises pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction, as taught by Le. One would have been motivated to have treated CRS comprising pyrexia and symptoms of HLH or MAS comprising hypotension and multi-organ dysfunction because Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS, and Le teaches that a characteristic of CRS includes fever, often occurring after CAR T-cell therapy.
Claims 1-8, 24-26, 29-30, 32-33, 35, and 37-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 10-12 of U.S. Patent No. 10,934,363 (‘363) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Kaiser et al., 2021 (04/14/2026 PTO-892).
The teachings of ‘363, Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that the patients with refractory multiple myeloma had received a median of 5 prior lines of treatment [page 2, third paragraph] and were triple refractory to a PI (proteasome inhibitor), IMiD (immunomodulatory drug), and anti-CD38 antibody, thereby indicating that these were prior lines of therapy [page 2, third paragraph], and Rioufol teaches that CAR T-cells are stored in bags or syringes (container; package) in cryogenic containers prior to administration [pages 2-3].
However, ‘363, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the composition further comprises an excipient of dimethyl sulfoxide at 5%.
Regarding claims 24-26 and 37-38, Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO (dimethyl sulfoxide) facilitates improved T cells recovery and functionality [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically formulated the composition of CAR T-cells, as taught by ‘363, Madduri, Dana-Farber, Rioufol, and ECA, to comprise 10% HAS and 5% DMSO, as taught by Kaiser. One would have been motivated to have formulated the CAR T-cells in a container (packaged) with 10% HAS and 5% DMSO (i.e. a ciltacabtagene autoleucel suspension) because Rioufol teaches that CAR T-cells are stored in bags or syringes for infusion in cryogenic containers prior to administration and Kaiser teaches that cryopreservation in serum-free freezing medium supplemented with 10% HAS and 5% DMSO facilitates improved T cells recovery and functionality.
Further regarding claims 25 and 26 of the instant application, the claims do not require any further steps that have not already been taught by the teachings above. The claims simply add the limitation of comprising a drug product label. MPEP 2112.01 (III) states “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art” In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Additionally, the Examiner is interpreting the CAR T cells of ‘363 and Madduri as an approved drug product, a limitation of instant claims 25-26, since the drug is administered to patients in order to treat refractory multiple myeloma.
Claims 1-8, 29-33, and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 10-12 of U.S. Patent No. 10,934,363 (‘363) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Yanez et al., 2019 (instant PTO-892).
The teachings of ‘363, Madduri, Dana-Farber, Rioufol, and ECA are above.
However, ‘363, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach administering a premedication for 30-60 minutes prior to administering to the subject the T cells and wherein the premedication comprises an antipyretic and an antihistamine.
Regarding claims 6 and 31, Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion [page 2, left column, second paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes, as taught by Yanez, prior to administering to the subject the T cells of Madduri in the method taught by ‘363, Madduri, Dana-Farber, Rioufol, and ECA. One would have been motivated to have administered a premedication of an antipyretic and an antihistamine 30-60 minutes prior to administering the T cells because Yanez teaches that some precautions are needed for the infusion of CAR T cells, one of which is pre-medication with acetaminophen (antipyretic) and diphenhydramine (antihistamine) that should be administered 30-60 minutes before the CAR T cell infusion. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
Claims 1-8, 29-30, 32-33, and 34-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 10-12 of U.S. Patent No. 10,934,363 (‘363) in view of Madduri et al., 2019 (12/22/2025 IDS), Dana-Farber, 2018 (04/14/2026 PTO-892), Rioufol et al., 2022 (04/14/2026 PTO-892), and ECA, 2017 (04/14/2026 PTO-892), as applied to claims 1-8, 29-30, 32-33, and 35 above, and further in view of Freyer et al., 2020 (instant PTO-892).
The teachings of ‘363, Madduri, Dana-Farber, Rioufol, and ECA are above. To reiterate, Madduri teaches that a majority of the patients treated had grade 1-2 CRS, and that tocilizumab and corticosteroids were administered to treat patients with CRS, and further, that 1 patient had grade 3 and 1 patient with grade 5 [page 2, paragraphs 4-5].
However, ‘363, Madduri, Dana-Farber, Rioufol, and ECA do not specifically teach that the corticosteroid is dexamethasone or methylprednisolone.
Regarding claim 34, Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS [page 945, left column, first paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered methylprednisolone or dexamethasone, as taught by Freyer, to the patient of Madduri with grade 3 CRS. One would have been motivated to have administered methylprednisolone or dexamethasone as taught by Freyer to the patient of Madduri with grade 3 CRS because Freyer teaches that methylprednisolone or dexamethasone are typically used for grade 3 CRS. Thus, there would be a reasonable expectation of success because this is a known parameter in the art.
Response to Arguments
The rejections of claims 1, 6-8, and 24 under 35 U.S.C. 112(b) are maintained. On page 12 of the remarks, Applicant argues that the term “about” is not per se indefinite and that the Federal Circuit and USPTO recognize that terms of degree, such as about, are acceptable when the specification provides some standard for measuring the scope of the term, citing MPEP 2173.05(b). Applicant further argues that the definition of “about” in the instant specification as “being within a statistically meaningful range of a value” [see paragraph 76 of the Specification]. These arguments are not found persuasive because while Applicant does explicitly define “about”, the definition is still indefinite because it relies on the interpretation of others for what is or is not acceptable, as stated in the previous rejection and the rejection maintained above. Applicant also argues that “statistically meaningful” is not impermissibly subjective and that a person of ordinary skill in the art would understand that “about” in the context of the claimed values encompasses minor deviations that would not materially affect the therapeutic outcome or safety profile of the treatment method. This is not found persuasive because, even if one would understand that “about” in the context of the claimed values encompasses minor deviations, this is still indefinite because it relies on the interpretation of others for what is or is not a “minor deviation”. Thus, the metes and bounds for “about” are dependent on the interpretation of others for determining what is a “meaningful” range which can lead to different interpretations on if the claim infringes with “about.” Therefore, the rejection is maintained. See above.
The rejections under 35 U.S.C. 103 over Madduri, Dana-Farber, Rioufol, and ECA are maintained. On page 15 of the remarks, Applicant argues that the cited references do not teach or suggest a method of treating multiple myeloma in a subject in need thereof with the specific combination of claim limitations and further argues on page 16 of the remarks that there is no pointer in Madduri which would have prompted the skilled person to modify its teaching in search for a different treatment condition, let alone the claimed specific conditions for the administration, much less is there any guidance in Madduri on how to do so, and the skilled person starting from Madduri would therefore not have been prompted to arrive at the claimed therapy. This is not persuasive because in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection is based upon the combination of the teachings of Madduri, Dana-Farber, Rioufol, and ECA. See rejection above. Additionally on page 16 of the remarks, Applicant argues that Dana-Farber, Rioufol, and ECA do not cure the deficiencies in Madduri because each of these references provides only general information about CAR-T cell therapy or pharmaceutical products that does not teach or suggest the specific administration protocol recited in amended claim 1. This is not persuasive because in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, as it pertains to the teachings of Rioufol, Applicant argues that Rioufol teaches a stability window of only 30 to 90 minutes, which is significantly shorter than the 2.5-hour administration window recited in the present claims, and therefore, a person of ordinary skill in the art following Rioufol's guidance would not have arrived at the claimed 2.5-hour window; rather, Rioufol teaches away from the claimed invention by suggesting that CAR-T cells should be administered within a much narrower timeframe. This is not found persuasive because the claimed limitation is “wherein the method comprises completing administering to the subject a dose of T cells within about 2.5 hours.” Thus, Rioufol’s teaching of a stability window of CAR-T cells of only 30 to 90 minutes is well within the 2.5 hours as claimed and therefore, Rioufol does not teach away from the claimed method but rather gives clear motivation as to why one of ordinary skill in the art would want to administer the T cells within 2.5 hours.
On page 17 of the remarks, Applicant argues that the Examiner has not established a proper motivation to combine the references with a reasonable expectation of success and that the mere fact that individual parameters (time and temperature) are "known" in the art does not establish that a person of ordinary skill in the art would have been motivated to combine them in the specific manner claimed for the specific CAR T therapy, i.e., ciltacabtagene autoleucel, much less establish a reasonable expectation that such a combination would be successful for treating multiple myeloma. This is not found persuasive because the Examiner clearly set forth in the rejection why one would have been motivated to have combined these references with a reasonable expectation of success and thus arrived at the claimed method. See rejection above. Applicant does not provide any objective evidence as to why one would not have had a reasonable expectation of success of following known parameters in the art to arrive at the claimed method. Applicant is reminded that “arguments of counsel cannot take place of factually supported objective evidence” (see MPEP §2145).
On page 18 of the remarks, Applicant argues that the teachings of Le do not cure the deficiencies of Madduri, Dana-Farber, Rioufol, and ECA. This is not found persuasive because no such deficiency exists. See above. On page 19 of the remarks, Applicant argues that the teachings of Kaiser do not cure the deficiencies of Madduri, Dana-Farber, Rioufol, and ECA. This is not found persuasive because no such deficiency exists. See above. Further, regarding claims 25 and 26, Applicant argues that the Applicants respectfully submit that the Examiner's reliance on MPEP 2112.01(III) is misplaced and that the claims are not merely adding "printed matter" to a prior art product, but rather, these claims recite specific pharmaceutical products and methods requiring FDA-approved drug products with corresponding drug product labels containing specific treatment instructions and that the drug product label is not merely printed matter but is an integral part of the regulatory approval process that defines the approved use of the product. This is not found persuasive because the Examiner did not misplace the MPEP citation and Applicant has not argued any functional relevance of the printed matter and the composition and has only argued that it is some portion of the approval process.
The double patenting rejections are maintained. On page 21 of the remarks, Applicant requests that the nonstatutory double patenting rejections be held in abeyance until the indication of allowable subject matter. A request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filled by applicant at this time.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
