Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1, 4, 10, 13-20, 33, 39, 42, 48, 52-55, and 57 are pending in the instant application.
Rejections Withdrawn
The rejection of claims 5 and 7 are moot in view of claim cancelation.
The rejection to claims 1, 4, 10, 13-17, 33, 39, 42, 48, 52-53, 55, and 57 under 35 U.S.C. 102 are withdrawn in view of claim amendment.
The rejection to claims 1, 4, 10, 13-20, 33, 39, 42, 48, 52-55, and 57 under 35 U.S.C. 103 are withdrawn in view of claim amendment.
Claim Rejections Necessitated by Claim Amendment
Claim Rejections – 35 USC § 102
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.
Claims 1, 4, 10, 13, 33, 39, 42, 48, 52-53, 55, and 57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herrera AF et al. (Blood 2016 128(22) 4194 reference of record) and evidenced by US 20160082120 (Polson A et al. reference of record), ADC Review Polatuzumab vedotin. (https://www.adcreview.com/polatuzumab-vedotin-drug-description/, Last Editorial Review and Update: June 12, 2019 reference of record), Hoffmann La Roche Clinical trial NCT02257567 (https://clinicaltrials.gov/study/NCT02257567? tab= history&a=43#version-content-panel Date 2017-11-22 reference of record), Matasar M et al. (Haematologica 2017; 102(s2) 173 reference of record).
Regarding instant claims 1, 4, 10, 33, 39, and 48, Herrera taught a method for treating Relapsed or Refractory DLBCL in a human in clinical trial NCT02257567, which by definition would be relapsed or refractory to a prior treatment (instant claim 48), comprising an effective amount of:
the immunoconjugate polatuzumab vedotin at a dose of 1.8 mg/kg;
the alkylating agent bendamustine at a dose of 90 mg/m2; and
Hoffmann La Roche evidenced bendamustine used in clinical trial NCT02257567 was Treanda, which is bendamustine-HCl (Hoffmann La Roche page 21, Drug: Bendamustine) which meets the claim limitations of instant claim 10;
the anti-CD20 antibody rituximab at a dose of 375 mg/m2 (page 2, Introduction and Methods),
wherein administering such treatment to a plurality of human patients having DLBCL would naturally result in at least a two-fold increase in the complete response (CR) rate in a plurality of human patients as compared to administering a control treatment to a plurality of human patients, wherein the control treatment comprises the bendamustine or a salt or solvate thereof and the rituximab in the absence of polatuzumab vedotin (instant claim 1), wherein the combination therapy was administered intravenously every 21 days for DLBCL patients for a total of 6 cycles (page 2, methods), wherein the treatment extends progression free survival as taught by DLBCL patients achieving a complete response (instant claim 4) (page 4, Table 2, PoV + BR), wherein DLBCL patients who achieved a complete response or partial response remained in remission with a median follow-up of 8.4 months with one patient remaining in response for 14 months which meets the claim limitations of instant claims 33 and 39. Herrera taught this combination therapy showed promising durable responses in heavily pretreated R/R DLBCL patients, wherein PoV combined with BR has an acceptable safety profile (Herrera page 3, conclusions).
Regarding instant claim 13, Hoffmann La Roche evidenced that the method taught by Herrera in clinical trial NCT02257567 administered:
the immunoconjugate polatuzumab vedotin intravenously on Day 2 of cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles at a dose of 1.8 mg/kg
the alkylating agent bendamustine-HCl (Treanda) intravenously on Day 2 and 3 of cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles at a dose of 90 mg/m2; and
the anti-CD20 antibody rituximab intravenously on Day 1 of each cycle for up to 6 cycles at a dose of 375 mg/m2 (Hoffmann La Roche, page 21, Polatuzumab+BR in DLBCL),
which meets the claim limitations of instant claim 13.
Regarding instant claim 42, Hoffmann La Roche evidenced that the method taught by Herrera in clinical trial NCT02257567 excluded patients with CNS lymphoma (Hoffmann La Roche, exclusion criteria, page 30, bullet 9).
Regarding instant claims 52 and 53, Hoffmann La Roche evidenced that the method taught by Herrera in clinical trial NCT02257567 was not eligible for an autologous stem cell transplantation (ASCT) (Hoffmann La Roche, exclusion criteria, page 30, bullet 6).
Regarding instant claim 55, Hoffmann La Roche evidenced that the method taught by Herrera in clinical trial NCT02257567 was eligible for the DLBCL combination treatment above if the patient had received prior bendamustine treatment (Hoffmann La Roche, inclusion criteria page 29, bullet 2).
Regarding instant claim 57, Matasar evidenced that the method taught by Herrera in clinical trial NCT02257567 had DLBCL patients refractory to last most recent treatment and prior transplant (page 173, right column, results).
Response to Arguments
The Applicant has amended the independent instant claim 1.
The updated rejections are above.
Applicants argue unexpected benefits wherein the observed complete response (CR) rate as assessed by the Independent Review Committee (IRC) at the end of treatment in the Phase lb/II stage of the clinical trial was up to 40% for patients treated with Pola-BR (see, Table 3 and para. [0365]), which is about 3-fold higher than the maximum CR rate previously observed with polatuzumab vedotin alone or combined with rituximab (up to 15%; see, paras. [0345] and [0385], and more than 2-fold higher than the CR rate for treatment of transplant-ineligible R/R DLBCL patients with BR (only 17 .5%, see, Table 3)
Applicants submit that the cited references are all silent on a method for treating relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in a human in need thereof comprising the administration of polatuzumab vedotin in combination with bendamustine or a salt or solvate thereof and rituximab, wherein administering such treatment to a plurality of human patients having R/R DLBCL results in (i) at least a two-fold increase in the complete response (CR) rate in a plurality of human patients as compared to administering a control treatment to a plurality of human patients, wherein the control treatment comprises the bendamustine or a salt or solvate thereof and the rituximab in the absence of polatuzumab vedotin and/or (ii) at least a two-fold increase in the objective response (OR) rate in a plurality of human patients as compared to administering a control treatment to a plurality of human patients, wherein the control treatment comprises the bendamustine or a salt or solvate thereof and the rituximab in the absence of polatuzumab vedotin. Accordingly, Applicants submit that claim 1 is novel over the cited art, and thus so too are all claims depending from claim 1. Applicants therefore respectfully request withdrawal of the rejection under 35 U.S.C. § 102.
In response, Applicant's arguments filed 3/20/2026 have been fully considered
but they are not persuasive. The unexpected benefits require claim 1 to further include the subject matter of claims 13 and instant claims 14-17, wherein instant claims 14-17 have not been rejected under 35 USC § 102. MPEP 716.02(d) states, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Regarding instant claim 1 and Herrera, Herrera taught a method for treating Relapsed or Refractory DLBCL in a human in clinical trial NCT02257567 detailed above, wherein administering such treatment to a plurality of human patients having DLBCL would naturally result in at least a two-fold increase in the complete response (CR) rate in a plurality of human patients as compared to administering a control treatment to a plurality of human patients, wherein the control treatment comprises the bendamustine or a salt or solvate thereof and the rituximab in the absence of polatuzumab vedotin. Thus, the method above meets the claim limitations of instant claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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, 4, 10, 13, 18-20, 33, 39, 42, 48, 52-53, 55, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Herrera AF et al. (Blood 2016 128(22) 4194 reference of record) and Darwish M et al. (Cancer Chemother Pharmacol. 2014; 73(6): 1119–1127 reference of record), Pichler WJ et al. (Allergy 2006 61 912–920 reference of record), Kim EG et al. (Biomol Ther (Seoul). 2015 Nov; 23(6): 493–509 reference of record), and Levin AS et al. (J Allergy Clin Immunol Pract 5 1 107-113 reference of record) and evidenced by US 20160082120 (Polson A et al. reference of record), ADC Review Polatuzumab vedotin. (https://www.adcreview.com/polatuzumab-vedotin-drug-description/, Last Editorial Review and Update: June 12, 2019 reference of record), and Hoffmann La Roche Clinical trial NCT02257567 (https://clinicaltrials.gov/study/NCT02257567? tab= history&a=43#version-content-panel Date 2017-11-22 reference of record), and Matasar M et al. (Haematologica 2017; 102(s2) 173 reference of record).
Herrera, as evidenced by Polson, ADC Review, Hoffmann La Roche, and Matasar, taught the limitations of claims 1, 4, 10, 13, 33, 39, 42, 48, 52-53, 55, and 57 for the reasons set forth above.
Herrera is silent to: 1) extending the combination therapy of polatuzumab vedotin, bendamustine, and rituximab for more than 6 cycles; and 2) the order of administration of rituximab, polatuzumab vedotin, and bendamustine, but this is obvious in view of Herrera teaching that PoV combined with BR has an acceptable safety profile and Darwish, Pichler, Kim, and Levine.
Regarding instant claim 20, Darwish taught in the bendamustine–rituximab combination study, rituximab (375 mg/m2) was administered as an intravenous infusion on day 1 of each 28-day cycle for 6–8 treatment cycles; bendamustine (90 mg/m2) was administered as a 30-min intravenous infusion following completion of the rituximab infusion on day 1 of each cycle and was repeated on day 2 of each cycle (page 1120, right column, Methods section, first paragraph). Darwish taught the lack of pharmacokinetic interaction between the two drugs (page 1119, Abstract, Results). Darwish taught neither bendamustine nor rituximab appears to affect systemic exposure of the other drug when co-administered (page 1119, Abstract, Conclusions).
Regarding instant claim 20, Pichler taught allergic reactions to biological agents are directed against the protein itself and the frequency of such reactions depends on the degree of humanization of the applied protein, which is often an antibody (page 915, right column, Degree of Humanization paragraph). Pichler taught while, e.g. mouse antibodies (almost not used any more) as well as chimeric antibodies have at least some xenogenic determinants on its constant part, which can elicit quite rapidly an immune response, humanized or fully human antibodies have a low immunogenicity as immunological tolerance exists to the constant part of the immunoglobulin antibody (page 915, right column, Degree of Humanization paragraph).
Regarding instant claim 20, Kim taught polatuzumab vedotin is a humanized antibody (page 497, Table 2). Kim taught rituximab is a chimeric anti-CD20 antibody (page 495, left column, first paragraph).
Regarding instant claim 20, Levin taught reactions to rituximab occur frequently and the safety of rechallenging patients after a reaction is not clear (page 107, Abstract, background). Levin taught that a grade 3 or 4 reaction should prompt referral to an allergy specialist for risk assessment before additional rituximab administration (page 107, Abstract, conclusions). Levin taught treatment with an anti-histamine H1 blocker after an initial reaction to rituximab as well as steroids, H2 blockers, and intravenous fluids in response to rituximab adverse reactions (page 109, right column, last paragraph).
Regarding instant claims 18-20, it would have been obvious for a person having ordinary skill in the art to take the method of Herrera above – and: 1) extend the combination therapy of polatuzumab vedotin, bendamustine, and rituximab for more than 6 cycles using the dosing of cycles 2-6; and 2) administering them sequentially in the order of i) rituximab, ii) polatuzumab vedotin, then iii) bendamustine when administered on the same day or bendamustine last when paired with only one antibody agent.
This is obvious because: 1a) Herrera taught the combination therapy of polatuzumab vedotin, bendamustine, and rituximab showed promising durable responses in heavily pretreated R/R DLBCL patients, wherein PoV combined with BR has an acceptable safety profile;1b) Cycles 2-6 have the same dosage schedule and could be replicated for more cycles. Thus, extending the treatment regimen using the same administration regimen that was effective and safe in cycles 2-6 would be expected to be effective successful in subsequent cycles; 2a) Darwish taught rituximab administration prior to bendamustine did not affect the pharmacokinetic systemic exposure of the either drug when co-administered in this sequence; 2b) Pichler taught allergic reactions occur in chimeric antibodies more than humanized antibodies; 2c) Kim taught rituximab is a chimeric antibody and polatuzumab vedotin is humanized. Thus, rituximab would be expected to cause more allergic reactions; and 2d) Levin taught reactions to rituximab occur frequently and a grade 3 or 4 reaction should prompt referral to an allergy specialist for risk assessment before additional rituximab administration. Thus, the method should be administered in the order of most likely to cause an adverse response to least likely to cause a response for the antibodies to ensure safe administration to the patient, wherein the chimeric antibody rituximab would be administered first, followed by the humanized polatuzumab vedotin, and then bendamustine or bendamustine last when paired with only one antibody agent.
There is a reasonable expectation of success because: 1a) Herrera taught the combination therapy of polatuzumab vedotin, bendamustine, and rituximab showed promising durable responses in heavily pretreated R/R DLBCL patients, wherein PoV combined with BR has an acceptable safety profile;1b) Cycles 2-6 have the same dosage schedule and could be replicated for more cycles. Thus, extending the treatment regimen using the same administration regimen that was effective and safe in cycles 2-6 would be expected to be effective successful in subsequent cycles; 2a) Darwish taught rituximab administration prior to bendamustine did not affect the pharmacokinetic systemic exposure of the either drug when co-administered in this sequence; 2b) Pichler taught allergic reactions occur in chimeric antibodies more than humanized antibodies; 2c) Kim taught rituximab is a chimeric antibody and polatuzumab vedotin is humanized. Thus, rituximab would be expected to cause more allergic reactions; and 2d) Levin taught reactions to rituximab occur frequently and a grade 3 or 4 reaction should prompt referral to an allergy specialist for risk assessment before additional rituximab administration. Thus, the method should be administered in the order of most likely to cause an adverse response to least likely to cause a response for the antibodies to ensure safe administration to the patient, wherein the chimeric antibody rituximab would be administered first, followed by the humanized polatuzumab vedotin, and then bendamustine or bendamustine last when paired with only one antibody agent.
This would produce a method of treating human patients with R/R DLBCL with the NOS subtype comprising administering:
the immunoconjugate polatuzumab vedotin intravenously on Day 1 of each subsequent cycle after 6 cycles at a dose of 1.8 mg/kg
the alkylating agent bendamustine-HCl (Treanda) intravenously on Days 1 and 2 of each subsequent cycle after 6 cycles at a dose of 90 mg/m2; and
the anti-CD20 antibody rituximab intravenously on Day 1 of each cycle after 6 cycles at a dose of 375 mg/m2 (instant claims 18-19),
wherein the anti-CD20 antibody rituximab is administered prior to the immunoconjugate, and wherein the immunoconjugate is administered prior to the alkylating agent on Day 1 of each 21-day cycle for every cycle after Cycle 6 which meets the claim limitations of instant claim 20:
Response to Arguments
The Applicant has amended the independent instant claim 1.
The updated rejections are above.
Applicants submit that Herrera is silent with regards to a method for treating relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in a human in need thereof comprising the administration of polatuzumab vedotin in combination with bendamustine or a salt or solvate thereof and rituximab, wherein administering such treatment to a plurality of human patients having DLBCL results in (i) at least a two-fold increase in the complete response (CR) rate in a plurality of human patients as compared to administering a control treatment to a plurality of human patients, wherein the control treatment comprises the bendamustine or a salt or solvate thereof and the rituximab in the absence of polatuzumab vedotin.
Applicants argue unexpected benefits wherein the observed complete response (CR) rate as assessed by the Independent Review Committee (IRC) at the end of treatment in the Phase lb/II stage of the clinical trial was up to 40% for patients treated with Pola-BR (see, Table 3 and para. [0365]), which is about 3-fold higher than the maximum CR rate previously observed with polatuzumab vedotin alone or combined with rituximab (up to 15%; see, paras. [0345] and [0385], and more than 2-fold higher than the CR rate for treatment of transplant-ineligible R/R DLBCL patients with BR (only 17 .5%, see, Table 3)
In response, Applicant's arguments filed 3/20/2026 have been fully considered
but they are not persuasive. The rejection of claim 1 and Herrera is discussed above.
The unexpected benefits require claim 1 to further include the subject matter of claims 13 and instant claims 14-17. MPEP 716.02(d) states, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). Regarding instant claims 18-20, in the absence of claim 1 further including the subject matter of claims 13 and instant claims 14-17, results that identify the surprising results of treatment of DLBCL patients with more than 6 cycles of the claimed regimen are necessary to overcome the prima facie obvious rejections.
Claims 1, 4, 10, 13, 18-20, 33, 39, 42, 48, 52-55, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Herrera AF et al. (Blood 2016 128(22) 4194 reference of record) and evidenced by US 20160082120 (Polson A et al. reference of record), ADC Review Polatuzumab vedotin. (https://www.adcreview.com/ polatuzumab-vedotin-drug-description/, Last Editorial Review and Update: June 12, 2019 reference of record), Hoffmann La Roche Clinical trial NCT02257567 (https://clinicaltrials.gov/study/NCT02257567?tab=history&a=43#version-content-panel Date 2017-11-22 reference of record), and Matasar M et al. (Haematologica 2017; 102(s2) 173 reference of record) as applied to claims 1, 4, 10, 13, 18-20, 33, 39, 42, 48, 52-53, 55, and 57 above, and further in view of Eldjerou L et al. (Transplantation and Cellular Therapy 24(3) supplement, S125 DOI:https://doi.org/10.1016/j.bbmt.2017.12.066 reference of record).
The teachings of Herrera, as evidenced by Polson, ADC Review, Hoffmann La Roche, and Matasar, are set forth above.
Herrera is silent to whether the transplant was an autologous stem cell transplant, but this is obvious in view of Eldjerou.
Regarding instant claim 54, Matasar evidenced that the method taught by Herrera in clinical trial NCT02257567 had DLBCL patients refractory to last most recent treatment and prior transplant (page 173, right column, results).
Eldjerou taught DLBCL, relapsed/refractory (r/r) disease remains a major cause of morbidity and mortality wherein at relapse, high-dose chemotherapy with autologous stem cell transplant (ASCT) is the preferred therapy for eligible patients (Abstract, background). Eldjerou taught although ASCT is standard treatment for eligible DLBCL patients: i) its benefits are limited, with high rates of relapse, poor prognosis after relapse following ASCT, and risk of secondary malignancies; and ii) there is an urgent need for novel therapies (Abstract, conclusions).
Regarding instant claim 54, it would have been obvious for a person having ordinary skill in the art to take the method of Herrera above with extended combination therapy of polatuzumab vedotin, bendamustine, and rituximab for more than 6 cycles using the dosing of cycles 2-6 – and 1) perform the method in DLBCL patients that have failed prior autologous stem cell transplantation.
This is obvious because: a) autologous stem cell transplantation is standard of care and the DLBCL patient population that failed transplantation was likely an autologous stem cell transplantation patient; and b) although ASCT is standard treatment for eligible DLBCL patients: i) its benefits are limited, with high rates of relapse, poor prognosis after relapse following ASCT, and risk of secondary malignancies. Thus, treatment of DLBCL patients that failed prior ASCT would require other therapies and the DLBCL would be effectively targeted by the combination treatment.
There is a reasonable expectation of success because: 1a) the method may have already been performed successfully on this patient population, and 1b) the DLBCL combination treatment of polatuzumab vedotin, bendamustine, and rituximab would target the cancer cells with an antibody drug conjugate, alkylating agent, and antibody in combination that was shown to have promising durable responses in heavily pretreated R/R DLBCL patients, wherein PoV combined with BR has an acceptable safety profile.
Response to Arguments
The Applicant has amended the independent instant claim 1.
The updated rejections are above.
The discussion regarding unexpected results is above.
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, 4, 10, 33, and 39 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-49 of U.S. Patent No. 11,000,510. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 1, 4, 10, 33, and 39, ‘510 copending claims 43 and 45 taught a method for treating relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL) in a human comprising administering to the human (a) polatuzumab vedotin, (b) rituximab, and (c) bendamustine or bendamustine hydrochloride, wherein the polatuzumab vedotin is administered at a dose of about 1.8 mg/kg, wherein the polatuzumab vedotin is administered at a dose of about 1.8 mg/kg once every three weeks; wherein the rituximab is administered at a dose of about 375 mg/m2 once every three weeks; and wherein the bendamustine or bendamustine hydrochloride is administered at a dose of about 90 mg/m2 on day 1 and day 2 every three weeks, wherein: 1) administering such treatment to a plurality of human patients having DLBCL would naturally result in at least a two-fold increase in the complete response (CR) rate in a plurality of human patients as compared to administering a control treatment to a plurality of human patients, wherein the control treatment comprises the bendamustine or a salt or solvate thereof and the rituximab in the absence of polatuzumab vedotin (instant claim 1); 2) wherein the human naturally achieves a complete response (CR) following the treatment with the immunoconjugate polatuzumab vedotin, the alkylating agent bendamustine hydrochloride (instant claim 4), and the anti-CD20 antibody rituximab (instant claim 10); 3) wherein the treatment naturally extends the progression free survival (PFS) of the human to at least about 6 months (instant claim 33); and 4) wherein the treatment extends the overall survival (OS) of the human to at least about 11 months (instant claim 39).
‘510 copending claims 1-42, 44, and 46-49 and taught methods for treating relapsed or refractory follicular lymphoma (RR FL) or relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL) in a human comprising administering to the human an effective amount of (a) an immunoconjugate comprising an anti-CD79b antibody linked to MMAE, (b) rituximab, and (c) an alkylating agent, wherein the alkylating agent is 4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid or a salt thereof.
Allowable Subject Matter
Claims 14-17 are objected to as being dependent upon a rejected base claim, but would be allowable is rewritten in independent form, including all of the limitations of the base claim and any intervening claims.
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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/J.J.S./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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