DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application claims priority to U.S. provisional applications 63/347,397, filed on 31 May 2022. The effective filing date is 31 May 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 30 October 2025 and 09 December 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. The IDS submitted on 19 September 2023 is in compliance with the provisions of 37 CFR 1.97, except for the noted references below. References A-E of the disclosed foreign patent documents were not considered, because translations were not provided. All other references were considered by the examiner.
Status of Application, Amendments, and/or Claims
Claims 1-100 are the original claims filed on 31 May 2023. In the preliminary amendment of 18 September 2023, claims 2, 3, 6, 15, 17, 29-31, 64, 67-69, and 71 are amended and claims 4, 5, 7-14, 16, 18-20, 22-28, 32-55, 57-63, 65, 66, 70, and 72-100 are cancelled. Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are pending and the subject of this office action.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 21, 29-31, 56, and 64 are rejected under 35 U.S.C. 103 as being obvious over US 2018/0134798 A1 (herein Chu) in view of NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
In regard to claims 1, 21, and 56, Chu teaches a method of dosing bispecific anti-CD20/anti-CD-3 antibodies for the treatment of cancers, such as B cell proliferative disorders (e.g. non-Hodgkin’s lymphoma), and in certain embodiments this may be a relapsed or refractory form of the disease (abstract, and [0018]). Chu discloses a bispecific antibody with anti-CD20 and anti-CD3 hypervariable regions amino acid sequences identical to those of mosunetuzumab, shown below ([0011]):
Anti-CD20:
HCDR1: GYTFTSYNMH
HCDR2: AIYPGNGDTSYNQKFKG
HCDR3: VVYYSNSYWYFDV
LCDR1: RASSSVSYMH
LCDR2: APSNLAS
LCDR3: QQWSFNPPT
Anti-CD3:
HCDR1: NYYIH
HCDR2: WIYPGDGNTKYNEKFKG
HCDR3: DSYSNYYFDY
LCDR1: KSSQSLLNSRTRKNYLA
LCDR2: WASTRES
LCDR3: TQSFILRT
Chu teaches a double-step fractionated, dose-escalating regimen that utilizes a 21-day cycle, in which the first cycle implements dose-escalation ([0216]). The first cycle comprises 3 doses, on days 1, 8, and 15, across which the range of administered mosunetuzumab increases from about 0.02 mg to about 4.0 mg (claim 1 of instant application discloses a C1D1 dose of 1 mg) in dose one (C1D1), about 0.05 mg to about 20.0 mg (claim 1 of instant application discloses a C1D2 dose of 2 mg) in dose two (C1D2), and about 0.2 mg to about 50 mg (claim 1 of instant application discloses a C1D3 dose of 60 mg) in dose three (C1D3) ([0216], [0007] and claim 1). Additionally, it is taught that subsequent cycles, numbering between 1 to 14, comprise a single dose on day one of the cycle with the range of administered mosunetuzumab spanning about 0.2 mg to about 50 mg ([0007] and [0093]). Chu effectively teaches all limitations of claims 1, 21, and 56. In regard to dose amounts for C1D1, C1D2, and C3D1, the claimed values fall within the ranges disclosed by Chu for the corresponding cycle/doses, and as highlighted in MPEP 2144.05, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, in regard to C1D3 and C2D1, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap, but are close enough that one skilled in the art would have expected them to have the same properties (see Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). Furthermore, one of skill in the art would be motivated with an expectation of success to optimize the method disclosed by performing routine optimization (including recited dosages and dose schedules) in order to optimize dosages, dosing methods, and repetition rates. It is not inventive to discover optimal or workable ranges by routine experimentation. An administering physician can easily determine optimum dosages, dosing methods and repetition rates (see in re Aller, 220 F.2d 454, 456 (CCPA 1955)).
Chu does not explicitly teach the dosing regimen described above for the treatment of relapsed or refractory non-Hodgkin’s lymphoma (NHL) for patients aged about 65 years old or older. However, Chu does list EBV-positive DLBCL of the elderly as one of many examples of cancer to which the invention relates ([0045]). It is also mentioned that the elderly population, aged 70 and above, is 2-fold more likely to develop cancer ([0002]). Thus, it would have been obvious to target the elderly population with the treatment and dosing regimen taught by Chu. This is further reinforced by the inclusion of an elderly cohort, cohort B, in ‘670. Additionally, Presley teaches that elderly patients represent a large portion of the cancer population, with the median age at cancer diagnosis being 66 (Introduction). Furthermore, elderly patients are more sensitive to adverse effects of treatment, and the more favorable toxicity profile of immunotherapy make it an attractive strategy for treatment (introduction). One of ordinary skill in the art would have been motivated to apply the teachings of Chu, a with a dosing regimen aimed at limiting adverse effects, to elderly patients, due to the more favorable benefit-risk profile of immunotherapy compared to more traditional cancer therapies.
In regard to claims 29-31, the claims establish efficacy limitations of the invention described in claim 21. MPEP 2121 states: “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability.” Since each element of claim 21 is taught by the prior art, efficacy similar to that illustrated in the instant application and set-out in claims 29-31 is presumed (see In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980)).
In regard to claim 64, the claims establish efficacy limitations of the invention described in claim 56. MPEP 2121 states: “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability.” Since each element of claim 56 is taught by the prior art, efficacy a similar to that illustrated in the instant application and set-out in claim 64 is presumed (see In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980)).
Claims 68, 69, and 71 are rejected under 35 U.S.C. 103 as being obvious over US 2018/0134798 A1 (herein Chu) in view of NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
In regard to claims 68, 69 and 71, Chu and ‘670 teach a treatment and dosing regimen for elderly patients with refractory or relapsed non-Hodgkin’s lymphoma, as discussed for claims 1 and 21.
Chu also teaches that the method may further comprise administering additional therapeutic agents to the patient either prior, subsequent or concurrent to the administration of mosunetuzumab (claims 44, 45, and 51, [0016]). It is also taught that the additional therapeutic agent may comprise one or more of the following: tocilizumab, an antipyretic, a corticosteroid, an anti-histamine ([0216], [0222], and [0024]). Chu teaches that methylprednisolone may be administered intravenously with a dosage of 1-2 mg/kg, which when considering the average weight of an elderly adult is between 60-80 kg is comparable to the about 80 mg dose disclosed in claim 71 ([0134]).
Chu does not teach specific timing of corticosteroid administration. Viardot teaches this deficiency.
Viardot teaches administering a bispecific T-cell engager (BiTE) antibody in relapsed/refractory diffuse large B-cell lymphoma (abstract). In the study patients receive 20 mg of dexamethasone at 6-12 hours and 1 hour before first infusion of the bispecific antibody (Materials and methods: Study design and treatment). The stated reason for this prophylactic dexamethasone treatment is to minimize the risk of cytokine release syndrome and neurological events.
It would have been obvious to one skilled in the art to combine the teachings of Chu, and ‘670 with the prophylactic dexamethasone treatment taught by Viardot. One would have been motivated to combine the teachings due to the reduced risk of cytokine release syndrome and neurological events, both of which are known to be associated with immunotherapy, provided by the prophylactic corticosteroid, dexamethasone, treatment. One would have reasonably anticipated success based on the teachings of Viardot.
Claims 2, 3, 6, 15, and 17 are rejected under 35 U.S.C. 103 as being obvious over US 2018/0134798 A1 (herein Chu) in view of NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
In regard to claim 2, Chu and ‘670 teach a treatment and dosing regimen for elderly patients with refractory or relapsed non-Hodgkin’s lymphoma, as discussed for claims 1, 21, and 56. These teachings render the following claimed limitations of the instant claim obvious:
(b)
Instant Limitation: “the R/R NHL is R/R follicular lymphoma (Fl), R/R transformed FL (trFL), or R/R diffuse large B cell lymphoma (DLBCL)”
Prior Art: Chu teaches the method described for claim, and further teaches that the method may be applied to relapsed or refractory diffuse-large B cell lymphoma ([0018]).
(c)
Instant Limitation: “the first, second, and third dosing cycles are 21-day dosing cycles”
Prior Art: Chu teaches 21-day dosing cycles ([0216]).
(d)
Instant Limitation: “the method comprises administering:
The C1D1, the C1D2, and the C1D3 on Days 1, 8, and 15, respectively of the first dosing cycle
The C2D1 on Day 1 of the second dosing cycle: and/or
The C3D1 on Day 1 of the third dosing cycle”
Prior Art: Chu teaches “In cycle 2 and beyond, in which the bispecific antibody is given as a single dose only,” and “patients receive the anti-CD20/anti-
CD3 bispecific antibody on Days 1, 8, and 15 of Cycle 1.” ([0216])
(e)
Instant Limitation: “the dosing regimen further comprises one or more additional dosing cycles; and/or”
Prior Art: Chu teaches the method described for claim 1 may include between 1 to 14 additional cycles ([0098]).
(f)
Instant Limitation: “mosunetuzumab is administered by intravenous infusion.”
Prior Art: Chu teaches intravenous infusion of a bispecific anti-CD20/anti-CD3 antibody ([0123]).
Chu does not teach the method of claim 1 wherein: the subject has relapsed after, or is refractory to, two or more prior lines of therapy. Budde teaches this deficiency.
Budde teaches that administration of mosunetuzumab, using step-up dosing, for the treatment of relapsed/refractory B-cell non-Hodgkin’s lymphoma has a manageable safety profile and durable complete responses (conclusion). In addition to teaching a dosing regimen, similar to that of the instant application, it is disclosed that patients in group B of the study (NCT02500407) had a median of 3 prior systemic therapies prior to enrollment, and that admission into the FL cohort required at least 2 prior failed systemic therapies (Results: Patients, Methods: Study Design, and Table 1). Thus, it would have been obvious to one skilled in the art to apply the method taught by Chu et al to patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma. The analysis performed by Budde shows that treatment with near identical conditions is effective when applied to a subset of patients meeting the limitations described in the instant claim, and provides clear motivation.
In regard to claims 3 and 6, Chu and Budde teach the method of treating an elderly patient having relapsed/refractory non-Hodgkin’s lymphoma with a double-step fractionated, dose-escalating regimen of mosunetuzumab administration, see 103 rejection of claim 2.
Budde further teaches that a requirement of eligibility into the FL cohort of patients in clinical trial NCT02500407 included prior participation in at least 2 failed systemic therapies (including anti-CD20-directed therapy) and that included patients have R/R FL graded between 1-3a (Methods: Study Design).
In regard to claims 15 and 17, Chu and Budde teach the method of treating an elderly patient having relapsed/refractory non-Hodgkin’s lymphoma with a double-step fractionated, dose-escalating regimen of mosunetuzumab administration, see 103 rejection of claim 2.
Chu further teaches that additional dosing cycles are 21 days in length and that a single mosunetuzumab dose of about 30 mg is administered on day 1 of each respective dosing cycle ([0010] and [0093]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 3, 4, 10, 15, 18, 20-25, 28, 36, 38-41, 43, 44, 51, 52, 54-56, 59-61, 88-90, 92, 95, 97-109, 111, 118-124, and 141, of U.S. Patent No. 11466094 (related to reference application, 2018/0134798 A1 (herein Chu)) in view of Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both documents describe a method for treating a B-cell cancer (i.e. non-Hodgkin’s lymphoma) using a bispecific anti-CD20 / anti-CD3 antibody (i.e. mosunetuzumab) comprising identical variable regions targeting CD20/CD3. U.S. Patent No. 11466094 differs from the instant application in that the claims do not specify the dosing regimen claimed in the instant application nor do they specify that the method be applied to elderly patients suffering from relapsed/refractory non-Hodgkin’s lymphoma, however these deficiencies are taught in the prior art, as described in the 103 section of this office action.
Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 21, 29, 31, 33, 35, 37, 38, 58, 60, 63, 75, 76, 79, 82, 92, 97, 102, 104, 108, 111, 113, 115, 120, 122, 125, 126, 129, 130, 134, 135, 137, 139, 140, 141, 142, and 145-185 of U.S. Patent No. 12351643 in view of 2018/0134798 A1 (herein Chu), Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both documents describe a method for treating a B-cell cancer (i.e. non-Hodgkin’s lymphoma) using a bispecific anti-CD20 / anti-CD3 antibody (i.e. mosunetuzumab) comprising identical variable regions targeting CD20/CD3. U.S. Patent No. 12351643 differs from the instant application in that the claims do not specify the dosing regimen claimed in the instant application nor do they specify that the method be applied to elderly patients suffering from relapsed/refractory non-Hodgkin’s lymphoma, however these deficiencies are taught in the prior art, as described in the 103 section of this office action.
Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are rejected on the ground of non-statutory double patenting as being unpatentable over 1, 38, 45, 48, 50, 81, 85, 87, 90, 91, 93, 96, 98, 99, 254, 273-275, 277, and 293 of U.S. Patent No. 12492261 in view of 2018/0134798 A1 (herein Chu), Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both documents describe a method for treating a B-cell cancer (i.e. non-Hodgkin’s lymphoma) using a bispecific anti-CD20 / anti-CD3 antibody (i.e. mosunetuzumab) comprising identical variable regions targeting CD20/CD3. U.S. Patent No. 12492261 differs from the instant application in that the claims do not specify the dosing regimen claimed in the instant application nor do they specify that the method be applied to elderly patients suffering from relapsed/refractory non-Hodgkin’s lymphoma, however these deficiencies are taught in the prior art, as described in the 103 section of this office action.
Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1, 38, 40, 42, 45, 48, 50, 81, 85, 87, 90, 91, 93, 98, 99, 254, 273-275, 277, 284-286, 288, and 293 of U.S. Patent No. 12492261 in view of 2018/0134798 A1 (herein Chu), Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both documents describe a method for treating a B-cell cancer (i.e. non-Hodgkin’s lymphoma) using a bispecific anti-CD20 / anti-CD3 antibody (i.e. mosunetuzumab) comprising identical variable regions targeting CD20/CD3. U.S. Patent No. 12492261 differs from the instant application in that the claims do not specify the dosing regimen claimed in the instant application nor do they specify that the method be applied to elderly patients suffering from relapsed/refractory non-Hodgkin’s lymphoma, however these deficiencies are taught in the prior art, as described in the 103 section of this office action.
Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-8, 10-12, 25, 51, 53, 55-62, 71, 73-83, 92, 94-103, 112, 114-119, and 124, of U.S. Patent No. 11186650 in view of 2018/0134798 A1 (herein Chu), Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both documents describe a method for treating a B-cell cancer (i.e. non-Hodgkin’s lymphoma) using a bispecific anti-CD20 / anti-CD3 antibody (i.e. mosunetuzumab) comprising identical variable regions targeting CD20/CD3. U.S. Patent No. 11186650 differs from the instant application in that the claims do not specify the dosing regimen claimed in the instant application nor do they specify that the method be applied to elderly patients suffering from relapsed/refractory non-Hodgkin’s lymphoma, however these deficiencies are taught in the prior art, as described in the 103 section of this office action.
Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 18, 22, 23, 27, 31, 36, 38, 47, 49, 51, 52, 54, 56, 57, 71, 73, 75, 77, 79, and 81 of co-pending Application No. 18/834135 in view of 2018/0134798 A1 (herein Chu), Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both documents describe a method for treating a B-cell cancer (i.e. non-Hodgkin’s lymphoma) using a bispecific anti-CD20 / anti-CD3 antibody (i.e. mosunetuzumab) comprising identical variable regions targeting CD20/CD3. co-pending Application No. 18/834135 differs from the instant application in that the claims do not specify the exact dosing regimen claimed in the instant application nor do they specify that the method be applied to elderly patients suffering from relapsed/refractory non-Hodgkin’s lymphoma, however these deficiencies are taught in the prior art, as described in the 103 section of this office action.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6, 15, 17, 21, 29-31, 56, 64, 67-69, and 71 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-30, 33-45, 51, 53-57, 59, 60, and 64--69 of co-pending Application No. 19/305991 in view of 2018/0134798 A1 (herein Chu), Viardot A, et al. (2016) Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma. Blood. 2016 Mar 17;127(11):1410-6 (herein Viardot), NCT05207670 (clinicaltrials.gov, first posted 26 January 2022) (herein ‘670) and Budde LE, et al. (2022) Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients with Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. J Clin Oncol. 2022 Feb 10;40(5):481-491 (herein Budde) with Presley CJ, et al. (2021) Immunotherapy in Older Adults with Cancer. J Clin Oncol. 2021 Jul 1;39(19):2115-2127 (herein Presley) providing additional evidentiary value.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both documents describe a method for treating a B-cell cancer (i.e. non-Hodgkin’s lymphoma) using a bispecific anti-CD20 / anti-CD3 antibody (i.e. mosunetuzumab) comprising identical variable regions targeting CD20/CD3. co-pending Application No. 19/305991 differs from the instant application in that the claims do not specify the exact dosing regimen claimed in the instant application nor do they specify that the method be applied to elderly patients suffering from relapsed/refractory non-Hodgkin’s lymphoma, however these deficiencies are taught in the prior art, as described in the 103 section of this office action.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims rejected.
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/MATTHEW CURRAN METCALF/ Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647