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 .
Change in Examiner
The Examiner for this patent application has changed. The current examiner is Alec Jon Peters, AU 1641.
Applicant’s amendments, filed 6/11/2026, is acknowledged.
Claims 3-11, 14, 16-21, 23, 25-61, 63-71, 74, 76-83, 85-87, 91-96, 98, 101-127, 131, and 132 are cancelled.
Claims 1, 2, 12, 13, 15, 24, 62, 72, 73, 75, 84, 88-90, 97, 99, 100, and 128-130 are currently pending.
Claims 1, 12, and 15 are independent claims.
Claims 129 and 130 stand as withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or Species.
Claims 1, 2, 12, 13, 15, 24, 62, 72, 73, 75, 84, 88-90, 97, 99, 100, and 128 are under examination.
In view of the amendments and remarks filed on 6/11/2026, the following rejections remain.
Claim Interpretation
Applicant has amended the claims to recite methods of treating DLBCL in a human patient in need thereof, wherein the DLBCL is a high-grade B-cell lymphoma (HGBL). This combination of DLBCL diagnosis and molecular classification of HGBL is known in the art. For example, Swerdlow et al. (Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15), titled: “The 2016 revision of the World Health Organization classification of lymphoid neoplasms”, teaches (pg. 2380-2381): “…MYC is rearranged in 5%to 15% of DLBCL, NOS, and is frequently associated with BCL2 or, to a lesser extent, BCL6 translocation, in the so-called “double-hit” or “triple-hit” lymphomas that are included in the updated WHO classification in the new category of high-grade B-cell lymphoma (HGBL), with rearrangements of MYC and BCL2 and/or BCL6…MYC protein expression is detected in a much higher proportion of DLBCL (30%-50%) and is associated with concomitant expression of
BCL2…these tumors do not carry MYC/BCL2 chromosomal alterations and have been named “double-expressor lymphoma”.
Therefore, the claims are interpreted to comprise methods of treating DLBCL that is also HGBL with rearrangements of MYC and BCL2 and/or BCL6 (i.e., “double-hit” or “triple-hit” DLBCL).
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 12, 13, 15, 22, 24, 72, 75, 84, and 128 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NCT04479267 (Version 20200716, clinicaltrials.gov/study/NCT04479267), as evidenced by the instant specification. This new grounds of rejection is necessitated by Applicant’s amendments.
NCT04479267 teaches a method of treating DLBCL in human patients, including DLBCL that is HGBL with MYC and BCL2 and/or BCL6 rearrangements (Conditions), comprising administration of prednisone, polatuzumab vedotin, rituximab, cyclophosphamide, and doxorubicin (Arms).
NCT04479267 is silent on the functional limitations recited in instant claims 1, 12, 13, 15, 22, and 24, however the reference teaches a method of treating HGBL DLBCL with the combination of therapeutics recited supra, which is a method comprising the same therapeutics administered at the same doses according to the same schedule to the patients having the same disease as instantly claimed. Accordingly, any outcomes achieved in practicing the Pola-R-CHP method of NCT04479267 are inherent to said method necessarily flow from its practice.
Results disclosed in the instant specification (e.g. Fig. 15, Fig. 27) demonstrate as much, for example DLBCL patients receiving the Pola-R-CHP regimen as disclosed by NCT04479267 achieved at least a 20% reduction in risk of disease progression and an unstratified hazard of about 0.77 as compared to control. Such outcomes are therefore inherent to the method of the prior art, and they need not have previously noticed for the method of the instant claims to be anticipated by the Pola-R-CHP protocol taught by NCT04479267. See MPEP §2112 (e.g. “I. Something which is old does not become patentable upon the discovery of a new property” and “II. Inherent feature need not be recognized at the relevant time”).
Regarding instant claim 2, NCT04479267 teaches that progression-free survival is measured from the start of treatment to date of progression or death (Secondary Outcome Measures 2), anticipating the claim limitations.
Regarding instant claims 72 and 75, NCT04479267 teaches that the combination therapy is administered for 6 21-day cycles (Arms), anticipating the claim limitations.
Regarding instant claim 84, NCT04479267 teaches the combination therapy is administered to the human patient (Arms), anticipating the claim limitations.
Regarding instant claim 97, NCT04479267 teaches treatments of both double-hit and triple-hit DLBCL HGBL (Conditions), anticipating the claim limitations.
Regarding instant claim 128, NCT04479267 teaches the disease progression/relapse is assessed by the Lugano response criteria (Primary Outcome Measures), anticipating the claim limitations.
The reference teaching anticipates the instantly claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 12, 13, 15, 22, 24, 62, 72, 73, 75, 84, 88-90, 97, 99, 100, and 128 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT04479267 (Version 20200716, clinicaltrials.gov/study/NCT04479267, supra) in view of Tilly et al. (Lancet Oncol. 2019 Jul;20(7):998-1010. doi: 10.1016/S1470-2045(19)30091-9. Epub 2019 May 14, in Office Action mailed on 12/12/2025), as evidenced by the instant specification. This new grounds of rejection is necessitated by Applicant’s amendments.
The teachings of NCT04479267 as evidenced by the instant specification are discussed supra. NCT04479267 does not teach specific dosages for the pola-R-CHP therapy, such as the one recited in instant claim 62.
Tilly et al., in the same field of endeavor, teaches methods of treating diffuse large B-cell lymphoma (DLBCL; Table 1), comprising six to eight 21-day cycles comprising IV administration of 750 mg/m2 cyclophosphamide, 50 mg/m2 doxorubicin, 375 mg/m2 rituximab, and 1.8 mg/kg polatuzumab vedotin on day 1 of each cycle and oral administration of 100 mg prednisone daily for days 1-5 of each cycle (Pg. 1000, § Procedures; Supplemental Protocol §4.3.2 Dosage, Administration, and Compliance). Tilly et al. teaches the regimen leads to improved PFS when compared to the same treatment without polatuzumab vedotin (Discussion): “[p]atients in our study were older than those in the control group of the GOYA…Additionally, a higher proportion of patients in this study achieved a complete response (77% vs 58%) and progression-free survival at 1 year (91% vs 81%)…”
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the instant application, to have modified the teachings of NCT04479267 in view of Tilly et al. to use the dosages of the polatuzumab-R-CHP of Tilly et al. in the treatment method of NCT04479267 (i.e., the limitations of instant claims 62 and 73) with a reasonable expectation of success, as Tilly et al. teaches effective dosages to use in the method of treatment of NCT04479267. One would have been motivated to make this change to used effective therapeutic dosages for the therapeutic combination of administration of prednisone, polatuzumab vedotin, rituximab, cyclophosphamide, and doxorubicin to treat DLBCL-HGBL.
Regarding instant claims 88-90, Tilly et al. teaches prednisone administration prior to polatuzumab vedotin, as well as 8 cycles of treatment (“Procedures”), meeting the claim limitations.
Regarding instant claims 97, 99, and 100, Tilly et al. teaches that prophylaxis for tumor lysis syndrome includes a hydration regimen of 3 L/day starting 1 or 2 days before the first study dose and 300 mg/day allopurinol starting 48-72 hours before Cycle 1 (Supplemental Protocol §5.1.7.1), meeting the claim limitations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1, 2, 12, 13, 15, 22, 24, 62, 72, 73, 75, 84, 88-90, 97, 99, 100, and 128 are rejected under 35 U.S.C. 103 as being unpatentable over Tilly et al. (supra) in view of Phuoc et al. (Drugs Context. 2019 Dec 2;8:2019-8-1. doi: 10.7573/dic.2019-8-1), as evidenced by Sehn et al. (J Hematol Oncol. 2020 Jun 6;13(1):71. doi: 10.1186/s13045-020-00900-7). This new grounds of rejection is necessitated by Applicant’s amendments.
Tilly et al. teaches a method of treating diffuse large B-cell lymphoma (DLBCL; Table 1), comprising six to eight 21-day cycles comprising IV administration of 750 mg/m2 cyclophosphamide, 50 mg/m2 doxorubicin, 375 mg/m2 rituximab, and 1.8 mg/kg polatuzumab vedotin on day 1 of each cycle and oral administration of 100 mg prednisone daily for days 1-5 of each cycle (Pg. 1000, § Procedures; Supplemental Protocol §4.3.2 Dosage, Administration, and Compliance).
Tilly et al. teaches that a higher proportion of patients receiving pola-R-CHP achieved a complete response (CR) and progression-free survival (PFS) at one year when compared to the control group of the contemporary “GOYA” trial (i.e. a “reference PFS”), despite a higher proportion of enrolled patients having characteristics prognostic for poor outcomes (Pg. 1009, ¶2-3). Sehn et al. is provided as an evidentiary reference to demonstrate the control group of GOYA were treated with the standard of care “R-CHOP” comprising a combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (Abstract).
Thus, Tilly et al. teaches a method of treating DLBCL in a human patient comprising administration of polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone, wherein the treatment has an improvement of PFS when compared to the same treatment without polatuzumab vedotin.
Tilly et al. does not teach HGBL DLBCL.
Phuoc et al., in the same field of endeavor, teaches high-grade DLBCL with gene rearrangements in MYC and BCL2, or “double-hit” DLBCL, has an aggressive phenotype and increases resistance to chemotherapy (Introduction): “… (DLBCL) encompasses a spectrum of pathologic and molecular subtypes with different biologic behaviors…(WHO) classification defines double-hit lymphoma (DHL) as HGBL harboring MYC rearrangement occurring with either a B-cell CLL/lymphoma 2 (BCL2) and/or B-cell CLL/lymphoma (BCL6) rearrangement…the synergistic effect of dysregulation of both MYC with BCL2 and/or BCL6 rearrangements promotes lymphomagenesis and increases resistance to chemotherapy…”
Phuoc et al. teaches that standard R-CHOP therapy is the standard of care for DLBCL, however double-hit high-grade DLBCL has resistance to the therapy (Chemoimmunotherapy): “…(rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) remains the standard of care for DLBCL. However, DHL, DEL, and MYC rearranged DLBCL/HGBL have inferior progression-free survival (PFS) and OS when treated with R-CHOP with 5-year PFS and OS approximately 20–30%...”
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of treatment of Tilly et al. in view of Phuoc et al. to try to use the treatment to treat HGBL DLBCL (i.e., the limitations of instant claim 1) with a reasonable expectation of success, as Tilly et al. teaches methods of treating DLBCL with polatuzumab vedotin R-CHOP that can be applied to treat patients with HGBL DLBCL. One would have been motivated to make this change for the purposes of using the improved treatment protocol of Tilly et al. to treat HGBL DLBCL, which Phuoc et al. teaches is resistant to the standard R-CHOP.
Regarding instant claim 2, Tilly teaches that disease progression is measured from the date of the first dose to the first occurrence of progression (Supplemental Protocol Pg. 19, § Activity Outcome Measures), meeting the claim limitations.
Regarding the functional outcomes recited in instant claims 12, 13, 15, and 24, Tilly et al. discloses a method of treating DLBCL with a modified R-CHP regimen wherein vincristine is substituted with polatuzumab vedotin (“Pola-R-CHP”) – a method comprising the same therapeutics administered at the same doses according to the same schedule to the patients having the same disease as instantly claimed. Accordingly, any outcomes achieved in practicing the Pola-R-CHP method of Tilly et al. in view of Phuoc et al. would be expected to would necessarily flow from its practice.
The recited outcome measures of the method according to the claims do not confer any features that would distinguish its practice from that of the method taught by Tilly et al. in view of Phuoc et al. (e.g. active steps, additional therapeutics, etc.). Even without knowledge said results, one of ordinary skill in the art would remain motivated by the combined teachings of Tilly et al. in view of Phuoc et al. to employ the Pola-R-CHP regimen to treat DLBCL HGBL. There would have been a reasonable expectation of success because Tilly et al. teaches that the preliminary results from the Pola-R-CHP Phase II trial compared favorably to the standard-of-care in a separate contemporary trial in spite of a high proportion of enrolled patients having characteristics prognostic for poor outcomes, and that (pg. 1009): “the proportion of patients with a response and with progression-free survival were similar across the biological subsets of diffuse large B-cell lymphoma”.
Additionally, an obvious formulation cannot become nonobvious simply by measuring and claiming an activity of the formulation in a particular context, “because ‘[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property.’” Persion Pharm., slip op. at 13 (Fed. Cir. Dec. 27, 2019) (citing Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012)); see also Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945) (“It is not invention to perceive that the product which others had discovered had qualities they failed to detect.”).
Regarding instant claims 62, 72, 73, 75, and 84, Tilly et al. teaches the method comprising (supra) six to eight 21-day cycles of IV administration of 750 mg/m2 cyclophosphamide, 50 mg/m2 doxorubicin, 375 mg/m2 rituximab, and 1.8 mg/kg polatuzumab vedotin on day 1 of each cycle and oral administration of 100 mg prednisone daily for days 1-5 of each cycle, meeting the claim limitations.
Regarding instant claims 88-90, Tilly et al. teaches prednisone administration prior to polatuzumab vedotin, as well as 8 cycles of treatment (“Procedures”), meeting the claim limitations.
Regarding instant claims 97, 99, and 100, Tilly et al. teaches that prophylaxis for tumor lysis syndrome includes a hydration regimen of 3 L/day starting 1 or 2 days before the first study dose and 300 mg/day allopurinol starting 48-72 hours before Cycle 1 (Supplemental Protocol §5.1.7.1), meeting the claim limitations.
Regarding instant claim 128, Tilly teaches that disease progression, including death from any cause, is assessed using the 2014 Lugano Response Criteria (Supplemental Protocol §3.4.3; Appendix 3), meeting the claim limitations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 2, 12, 13, 15, 22, 24, 62, 72, 73, 75, 84, 88-90, and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 10, 15, 24, 31, 72-76, 80, 87, 89-91, 118, and 128 of copending Application No. 18/681,787 (App ‘787), as evidenced by the instant specification. Although the claims at issue are not identical, they are not patentably distinct from each other. This new grounds of rejection is necessitated by Applicant’s amendments.
App ‘787 teaches methods of treating HBL DLBCL in a human comprising administration of polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone, wherein the administration results in improvement of PFS when compared to the treatment in patients without polatuzumab vedotin, anticipating the limitations of instant claim 1. App ‘787 additionally claims PFS is measured from the start of treatment to the time or a first occurrence of disease progression, relapse, or death, anticipating the limitations of instant claim 2.
App ‘787 is silent on the functional limitations recited in instant claims 12 and 13, however the reference teaches a method of treating HGBL DLBCL with the combination of therapeutics recited supra, which is a method comprising the same therapeutics administered at the same doses according to the same schedule to the patients having the same disease as instantly claimed. Accordingly, any outcomes achieved in practicing the Pola-R-CHP method of App ‘787 are inherent to said method necessarily flow from its practice.
Results disclosed in the instant specification (e.g. Fig. 15, Fig. 27) demonstrate as much, for example DLBCL patients receiving the Pola-R-CHP regimen as claimed by App ‘787 achieved at least a 20% reduction in risk of disease progression and an unstratified hazard of about 0.77 as compared to control. Such outcomes are therefore inherent to the method of the prior art, and they need not have previously noticed for the method of the instant claims to be anticipated by the Pola-R-CHP protocol claimed by App ‘787. See MPEP §2112 (e.g. “I. Something which is old does not become patentable upon the discovery of a new property” and “II. Inherent feature need not be recognized at the relevant time”).
App ‘787 additionally claims a hazard ratio of no more than 0.4 (claim 15), anticipating the limitations of instant claims 15 and 22. App ‘787 additionally claims the CI claimed in instant claim 24 (App ‘787 claim 24).
App ‘787 additionally claims administration of 750 mg/m2 cyclophosphamide, 50 mg/m2 doxorubicin, 375 mg/m2 rituximab, and 1.8 mg/kg polatuzumab vedotin on day 1 of each cycle and oral administration of 100 mg prednisone (claim 1), anticipating the limitations of instant claims 62 and 84.
App ‘787 further claims the limitations of instant claims 72 and 73 (App ‘787 claims 72 and 73), as well as the treatment lasting at least 6 21-day cycles (i.e., the limitations of instant claim 75, App ‘787 claim 76).
Regarding instant claim 88, App ‘787 claims prednisone administered prior to the other therapeutics (claim 87), anticipating the claim limitations.
Regarding instant claims 89 and 90, App’ 787 claims 8 cycles of the full therapy (claims 89-91), anticipating the claim limitations.
Regarding instant claim 97, App ‘787 claims an IPI score of 2 or greater (claim 3), anticipating the claim limitations.
The instantly claimed invention is anticipated by the invention claimed by App ‘787. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 12, 13, 15, 22, 24, 62, 72, 73, 75, 84, 88-90, 97, 99, 100, and 128 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 10, 15, 24, 31, 72-76, 80, 87, 89-91, 118, and 128 of copending Application No. 18/681,787 (supra) in view of Tilly et al. (Lancet Oncol. 2019 Jul;20(7):998-1010. doi: 10.1016/S1470-2045(19)30091-9. Epub 2019 May 14, in Office Action mailed on 12/12/2025, supra), as evidenced by the instant specification.
The invention claimed by App ‘787 as evidenced by the instant specification has been discussed supra. App ‘787 does not claim the limitations of instant claim 99, 100, or 128.
Tilly et al., in the same field of endeavor, teaches prophylaxis for tumor lysis syndrome, a side effect of the pola-R-CHP treatment of HGBL DLBCL includes a hydration regimen of 3 L/day starting 1 or 2 days before the first study dose and 300 mg/day allopurinol starting 48-72 hours before Cycle 1 (Supplemental Protocol §5.1.7.1). Tilly et al. additionally teaches that disease progression, including death from any cause, is assessed using the 2014 Lugano Response Criteria (Supplemental Protocol §3.4.3; Appendix 3).
It would have been obvious to one with ordinary skill in the art to have modified App ‘787 in view of Tilly et al. to add prophylaxis for tumor lysis syndrome and use the Lugano Response Criteria to assess disease progression with a reasonable expectation of success, as Tilly et al. teaches both of these in treatments of DLBCL with pola-R-CHP. One would have been motivated to make these changes to provide prophylaxis to tumor lysis syndrome in the method of treatment claimed by App ‘787, as well as having a standardized Lugano Response Criteria assessment to assess disease progression.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of App ‘787 in view of Tilly et al., especially in absence of evidence to the contrary. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
