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 .
Claim Status
Applicant’s amendments and remarks, filed 12/10/2025, are acknowledged.
Claims 1-107 and 111-113 are canceled.
Claim 109 is amended.
Claims 108-110 are pending.
As such, claims 108-110 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/10/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/10/2025 was filed after the mailing date of the final Office Action on 06/10/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the foreign application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed foreign application, EP Application No. 20211862.6, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The present claims are drawn to a method of treating follicular lymphoma comprising administering an antibody that binds to human CD19, lenalidomide, and rituximab on a 28-day cycle. Foreign application EP20211862.6 fails to disclose of the instantly claimed dosing schedule; specifically, a 28-day cycle. Accordingly, claims 108-110 are not entitled to the benefit of this prior application. However, Examiner acknowledges that EP21158806.6, filed 02/23/2021, do disclose of the instantly claimed dosing schedule. Therefore, the instant claims have a priority date of 02/23/2021.
If Applicant disagrees with the examiner’s factual determination above, Applicant should provide evidence as to where the relevant features were disclosed in the earlier-filed application. This could be accomplished, for example, by pointing to specific pages or figures within the foreign application that disclose the now-claimed invention.
Withdrawn Rejections
Applicant’s arguments, see pages 4 and 5, filed 12/10/2025, with respect to claim 109 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims and the teachings of Peñalver et al provided in the IDS filed 12/10/2025 . As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s remarks, see pages 5-12, filed 12/10/2025, with respect to claims 108-110 rejected under 35 USC 103 as being unpatentable over Jurczak et al. (Annals of Oncology 29: 1266–1272, 2018), Becnel et al. (Blood (2017) 130 (Suppl_1) : 4040), Leonard et al. (J Clin Oncol 37:1188-1199, 2019), and Duell et al. (Blood (2019) 134 (Supplement_1): 1582) have been fully considered and are persuasive. Further, Examiner acknowledges that the teachings of Burke references the combination of tafasitamab, lenalidomide, and rituximab for treating DLBCL comprising a different treatment regimen of the presently claimed. As such, the 103 rejection is withdrawn.
Applicant’s remarks, see pages 12-17, filed 12/10/2025, with respect to claims 108-110 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending application no. 17/605,285 in view of Endell, Jurczak, Becnel, and Duell; claims 108-110 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending application no. 17/773,117 in view of Jurczak, Becnel, Leonard, and Duell; and, claims 108-110 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending application no. 18/773,766 in view of Jurczak, Becnel, Leonard, and Duell have been fully considered and are persuasive. As such, the provisional double patenting rejections are withdrawn.
New Rejections
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.
Claims 108-110 are rejected under 35 U.S.C. 103 as being unpatentable over Leonard et al. (J Clin Oncol 37:1188-1199, 2019; the reference was provided in a previous Office Action, mailed 12/21/2023) and further in view of Salles et al (Lancet Oncol 2020; 21: 978–88; published online: 06/05/2020), as evidenced by Wang et al (Leukemia (2013) 27, 1902–1909).
Leonard et al. disclose a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma (see entire document). Patients (MZL or FL (grades 1 to 3a)) were randomly assigned to lenalidomide plus rituximab or placebo plus rituximab (see pg. 1189, col. 1). Leonard et al disclose that the eligible patients in the study had at least one prior chemotherapy, immunotherapy, or chemoimmunotherapy and two or more previous doses of rituximab; and relapsed, refractory, or progressive disease and not rituximab-refractory disease (see pg. 1189, left column). The lenalidomide plus rituximab group dosing included oral lenalidomide 20 mg daily on days 1-21 plus intravenous rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1 (28-day cycles) and day 1 of cycles 2 to 5 every 28 days (see pg. 1189, col. 1). Leonard et al. disclose that PFS was significantly improved for the lenalidomide plus rituximab group compared to the placebo group, with a hazard ratio of 0.46 and median duration of 39.4 months vs. 14.1 months, respectively (see Abstract).
Leonard et al. disclose that the rituximab regimen was selected using efficacy and statistical assumptions from the LYM-3001 trial (ClinicalTrials.gov identifier: NCT00312845) in similar patients (see pg. 1189, col. 1). Additionally, the Appendix discloses that the choice of the rituximab schedule took into consideration studies showing that extended dosing of rituximab with four additional infusions (total eight infusions) further improves efficacy with acceptable toxicity, which has led to the approval of four or eight doses of rituximab in certain countries, including the United States; the totality of published studies showed that extended dosing (i.e., additional doses of rituximab beyond standard four weekly infusions) further improves benefit in a manner that is independent of the number or schedule of extended rituximab dosing (see “Appendix – Methods”). Further, the Appendix discloses that lenalidomide 20 mg was chosen based on published studies indicating that the combination of lenalidomide 20 mg with rituximab is well tolerated and active in relapsed/refractory indolent non-Hodgkin lymphoma whereas 25 mg lenalidomide in combination with rituximab was not tolerated because of grade 3 tumor lysis syndrome in two out of four patients (see “Appendix -Methods”).
Leonard et al, however, fails to disclose of administering the CD19 antibody as claimed. This is remedied by Salles et al.
Salles et al disclose of administering tafasitamab and lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (see entire document). While Salles et al does not explicitly disclose of the structure of tafasitamab, the antibody described by Salles et al shares the same name and properties as the anti-CD19 antibody recited in the present application thus inherently comprises the sequences set forth in instant claim 108 (see pg. 979, left col.; see MPEP 2112(III)). Salles et al disclose that treatment comprised of coadministration of tafasitamab and lenalidomide for up to 12 cycles (28 days each) (see pg. 980, right col.). Salles et al disclose of administering tafasitamab intravenously at a dose of 12 mg/kg over approximately 2 hours (see pg. 980, right col.). For cycles 1-3, tafasitamab was administered weekly on days 1, 8, 15, and 22; an additional loading dose was administered on day 4 of cycle 1; from cycle 4, tafasitamab was administered every 14 days, on days 1 and 15 of each cycle (see pg. 980, right col.). Salles et al disclose that patients self-administered lenalidomide capsules orally, starting with 25 mg daily on days 1-21 of each 28-day cycle; a stepwise dose reduction (decrease by 5 mg per day in each step, only once per cycle, without re-escalation) of lenalidomide was done in cases of protocol-defined toxicities (see pg. 980, right col.). Salles et al disclose that the combination of tafasitamab and lenalidomide was well tolerated
As such, it would have been obvious to combine the teachings of Leonard et al and Salles et al to develop the present invention. First, Leonard et al establishes that administering lenalidomide and rituximab with the claimed dosing regimen was effective for treating follicular lymphoma (including refractory or Grades 1-3a follicular lymphoma). Second, Salles et al disclose that administering tafasitamab and lenalidomide was effective for treating refractory or relapsed DLBCL. While the dosing regimen for Salles et al includes an additional loading dose in cycle 1 and a higher dose of lenalidomide, Applicant is reminded that the dosing regimen of the present claims does not exclude any additional elements, such as a loading dose in one of the cycles, under the broadest reasonable interpretation. Further, with respect to the higher dose of lenalidomide, the Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) indicated that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. Because daily lenalidomide has been proven effective for relapsed or refractory follicular lymphoma and DLBCL as taught by Leonard et al and Salles et al, and evidenced by Wang et al (see Abstract; page 1903, left col.; Table 3), one would have a reasonable expectation that administering tafasitamab and lenalidomide at the claimed dosing regimen would treat follicular lymphoma.
Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by administering tafasitamab and lenalidomide that treated relapsed or refractory DLBCL as taught by Salles et al in combination with lenalidomide and rituximab that treated relapsed or refractory follicular lymphoma as taught by Leonard et al, one would achieve a method for treating follicular lymphoma comprising administering tafasitamab, lenalidomide, and rituximab. Furthermore, Wang et al disclose that oral lenalidomide with rituximab treated relapsed or refractory diffuse large cell, follicular and transformed lymphoma (see Abstract; page 1903, left col.; Table 3). Thus, the teachings of Leonard et al, Salles et al, and Wang et al render the present invention obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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