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 .
Claims 50, 53, 57-60, 62 and 64-66 are under consideration
Rejections Withdrawn
The 35 USC § 112(b) rejections of claims 58 and 62 have been withdrawn in view of claim amendments.
All 35 USC § 103 and NDSP rejections have been withdrawn in view of claim amendments.
New Rejections Necessitated by Amendment
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.
Claim(s) 50, 53, 57-60, 62 and 64-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Berkel (Van Berkel, et al., WO 2014/057117 A1; Published 04/17/2014; Priority to 10/12/2012 by way of US 61/712,924, of record).
Van Berkel teaches on the subject of conjugates of an anti-CD19 antibody with PBD dimers (Van Berkel, Abstract). Regarding the ADC limitation of claims 53 and 62, Van Berkel teaches “compound E” of Van Berkel, which is the same as the drug-linker-crosslinker moiety as ADCX19 as disclosed in the instant Specification (Van Berkel, p 11, line 4) that is conjugated to antibody RB4v1.2 of Van Berkel, which comprises VH and VL of Van Berkel’s SEQ ID NOs: 2 and 8, respectively (same as instant SEQ ID NOs: 2 and 8, respectively) (Van Berkel, p 168, lines 16-25). Regarding of claim 50, Van Berkel teaches that the conjugates of Van Berkel are administered in the treatment of proliferative diseases (Van Berkel, p 81, lines 21-24) including DLBCL (Van Berkel, p 82, lines 13-17). Regarding claim 58, Van Berkel teaches that the diseases treated by the conjugates of Van Berkel are characterized by the overexpression of the target antigen (same as CD19+) (Van Berkel, p 82, lines 19-24). Regarding claims 59-60 and 65-66, Van Berkel teaches that the conjugates of Van Berkel are administered in combination with other treatments, including the administration of chemotherapeutic agents (Van Berkel, p 84, lines 4-15), with Van Berkel’s definition of “chemotherapeutic agent” including the therapeutic antibodies rituximab and ofatumumab (Van Berkel, p 87, lines 1-7), either simultaneously or sequentially (Van Berkel, p 84, line 4-6).
Van Berkel does not teach a method of treating relapsed or refractory DBLCL, said method comprising administering ADCx19 in conjunction with rituximab and ofatumumab.
It would be prima facie obvious to one of ordinary skill in the art combine the ADCx19, rituximab and ofatumumab all taught by Van Berkel to form a method of treating relapsed or refractory DBLCL, said method comprising administering ADCx19 in conjunction with rituximab and ofatumumab. One of ordinary skill in the art would be motivated to do this in order to better treat DBLCL. Van Berkel teaches administration of ADCx19 for DBLCL as well as the administration of rituximab and rituximab and ofatumumab but does not teach this specific combination. The combination of ADCx19 with rituximab and ofatumumab for treating DBLCL is an obvious combination by virtue of the fact that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… the idea of combining them flows logically from there having been individually taught in the prior art (see MPEP § 2144.06). In the instant case, Van Berkel teaches ADCx19, rituximab and ofatumumab and DBLCL. One of ordinary skill in the art would have a reasonable expectation of success forming a method of treating relapsed or refractory DBLCL, said method comprising administering ADCx19 in conjunction with rituximab and ofatumumab because Van Berkel teaches ADCx19, rituximab and ofatumumab for DBLCL.
With respect to the “relapsed or refractory” limitation, the broadest reasonable limitation of “relapsed or refractory” would include DBLCL that is refractory to chemotherapeutics and one of ordinary skill would expect that the ADCx19, rituximab and ofatumumab of Van Berkel would not be impeded by the refractoriness of the cancers because antibody and antibody drug conjugate-based anti-cancer medications work via different mechanisms than chemotherapeutics.
Response to Arguments
Applicant supplied no arguments regarding this rejection specifically.
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 50, 53, 57-60, 62 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over
Claims 1-16 of U.S. Patent No. 9,931,414 B2
claims 1-11 of U.S. Patent No. 10,780,181 B2
both in view of Van Berkel (Van Berkel, et al., WO 2014/057117 A1; Published 04/17/2014; Priority to 10/12/2012 by way of US 61/712,924, of record).
The reference patents are both drawn to antibody drug conjugates comprising anti-CD19 antibodies that comprise VH and VL sequences identical to instant SEQ ID NOs: 2 and 8, respectively and further comprising drug-linker-crosslinker moieties that are identical to ADCx19 of the instant application. The reference patents also teach methods of treating cancer comprising administration of the patented ADCs in conjunction with the antibody rituximab.
The reference patents do not teach that that the ADCs of the reference patents are administered in a method of treating relapsed or refractory DLBCL that expresses CD19, said method comprising administration of the ADC of the reference patents, rituximab and ofatumumab.
Van Berkel teaches on the subject of conjugates of an anti-CD19 antibody with PBD dimers (Van Berkel, Abstract). Van Berkel teaches “compound E” of Van Berkel, which is the same as the drug-linker-crosslinker moiety as ADCX19 as disclosed in the instant Specification (Van Berkel, p 11, line 4) that is conjugated to antibody RB4v1.2 of Van Berkel, which comprises VH and VL of Van Berkel’s SEQ ID NOs: 2 and 8, respectively (same as instant SEQ ID NOs: 2 and 8, respectively) (Van Berkel, p 168, lines 16-25). Van Berkel teaches that the conjugates of Van Berkel are administered in the treatment of proliferative diseases (Van Berkel, p 81, lines 21-24) including DLBCL (Van Berkel, p 82, lines 13-17). Van Berkel teaches that the diseases treated by the conjugates of Van Berkel are characterized by the overexpression of the target antigen (same as CD19+) (Van Berkel, p 82, lines 19-24). Van Berkel teaches that the conjugates of Van Berkel are administered in combination with other treatments, including the administration of chemotherapeutic agents (Van Berkel, p 84, lines 4-15), with Van Berkel’s definition of “chemotherapeutic agent” including the therapeutic antibodies rituximab and ofatumumab (Van Berkel, p 87, lines 1-7), either simultaneously or sequentially (Van Berkel, p 84, line 4-6).
It would be prima facie obvious to one of ordinary skill in the art to combine the ADC of the reference patents with the rituximab and ofatumumab of Van Berkel to form a method of treating relapsed or refractory DBLCL, said method comprising administering the ADCs of the reference patents in conjunction with rituximab and ofatumumab. One of ordinary skill in the art would be motivated to do this in order to better treat DBLCL. Van Berkel teaches administration of the ADCs identical to the ADCs of the reference patents for DBLCL as well as the administration of rituximab and ofatumumab. The combination of the ADCs of the reference patents with rituximab and ofatumumab for treating DBLCL is an obvious combination by virtue of the fact that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… the idea of combining them flows logically from their having been individually taught in the prior art (see MPEP § 2144.06). In the instant case, Van Berkel teaches ADCx19 (identical to the ADC of the reference patents), rituximab and ofatumumab for DBLCL.
With respect to the “relapsed or refractory” limitation, the broadest reasonable limitation of “relapsed or refractory” would include DBLCL that is refractory to chemotherapeutics and one of ordinary skill would expect that the ADC of the reference patents and the rituximab and ofatumumab of Van Berkel would not be impeded by the refractoriness of the cancers because antibody and antibody drug conjugate-based anti-cancer medications work via different mechanisms than chemotherapeutics.
Response to Arguments
Applicant supplied no arguments regarding this rejection specifically.
Claims 50, 53, 57-60, 62 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,889,207 B2 in view of Van Berkel (Van Berkel, et al., WO 2014/057117 A1; Published 04/17/2014; Priority to 10/12/2012 by way of US 61/712,924, of record)
Although they are not identical, the patented and instant claims are not patentably distinct because the instant claimed method requires an ADC taught in the ‘207 patent. With respect to the “ADCx19” limitations, patented claims 1, 13, 15 and 17 are directed to a drug-linker-crosslinker moiety identical to the drug-linker-crosslinker moiety of the instant ADCx19 conjugated to an antibody. Regarding the anti-CD19 limitations, patented claim 5 is directed to anti-CD19 antibodies.
The ’207 patent does not teach that that the ADC of the ‘207 patent comprises VH and VL sequences of instant SEQ ID NOs: 2 and 8, respectively and are administered in a method of treating relapsed or refractory DLBCL that expresses CD19, said method comprising administration of the ADC of the reference patents, rituximab and ofatumumab.
Van Berkel teaches on the subject of conjugates of an anti-CD19 antibody with PBD dimers (Van Berkel, Abstract). Van Berkel teaches “compound E” of Van Berkel, which is the same as the drug-linker-crosslinker moiety as ADCX19 as disclosed in the instant Specification (Van Berkel, p 11, line 4) that is conjugated to antibody RB4v1.2 of Van Berkel, which comprises VH and VL of Van Berkel’s SEQ ID NOs: 2 and 8, respectively (same as instant SEQ ID NOs: 2 and 8, respectively) (Van Berkel, p 168, lines 16-25). Van Berkel teaches that the conjugates of Van Berkel are administered in the treatment of proliferative diseases (Van Berkel, p 81, lines 21-24) including DLBCL (Van Berkel, p 82, lines 13-17). Van Berkel teaches that the diseases treated by the conjugates of Van Berkel are characterized by the overexpression of the target antigen (same as CD19+) (Van Berkel, p 82, lines 19-24). Van Berkel teaches that the conjugates of Van Berkel are administered in combination with other treatments, including the administration of chemotherapeutic agents (Van Berkel, p 84, lines 4-15), with Van Berkel’s definition of “chemotherapeutic agent” including the therapeutic antibodies rituximab and ofatumumab (Van Berkel, p 87, lines 1-7), either simultaneously or sequentially (Van Berkel, p 84, line 4-6).
It would be prima facie obvious to one of ordinary skill in the art to combine the ADC of the ‘207 patent with the rituximab and ofatumumab Van Berkel to form a method of treating relapsed or refractory DBLCL, said method comprising administering the ADC of the ‘207 patent in conjunction with rituximab and ofatumumab. One of ordinary skill in the art would be motivated to do this in order to better treat DBLCL. Van Berkel teaches administration of the ADCs of the ‘207 patent for DBLCL as well as further administration of rituximab and ofatumumab. The combination of the ADC of the ‘207 patent with ibrutinib for treating DBLCL is an obvious combination by virtue of the fact that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… the idea of combining them flows logically from their having been individually taught in the prior art (see MPEP § 2144.06). In the instant case, Van Berkel teaches ADCx19 (identical to the reference ADC), rituximab and ofatumumab for DBLCL.
With respect to the “relapsed or refractory” limitation, the broadest reasonable limitation of “relapsed or refractory” would include DBLCL that is refractory to chemotherapeutics and one of ordinary skill would expect that the ADC of the ‘207 patent and the rituximab and ofatumumab of Van Berkel would not be impeded by the refractoriness of the cancers because antibody and antibody drug conjugate-based anti-cancer medications work via different mechanisms than chemotherapeutics.
Response to Arguments
Applicant supplied no arguments regarding this rejection specifically.
Claims 50, 53, 57-60, 62 and 64-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,646,584 B2 in view of Van Berkel (Van Berkel, et al., WO 2014/057117 A1; Published 04/17/2014; Priority to 10/12/2012 by way of US 61/712,924)
Although they are not identical, the patented and instant claims are not patentably distinct because the instant claimed method requires an ADC taught in the ‘584 patent. With respect to the “ADCx19” limitations, patented claim 1 is directed to a drug-linker-crosslinker moiety identical to the drug-linker-crosslinker moiety of the instant ADCx19 conjugated to an antibody. Regarding the anti-CD19 limitations, patented claim 4 is directed to anti-CD19 antibodies.
The ’584 patent does not teach that that the ADC of the ‘584 patent comprises VH and VL sequences of instant SEQ ID NOs: 2 and 8, respectively and are administered in a method of treating relapsed or refractory DLBCL that expresses CD19, said method comprising administration of the ADC of the reference patents, rituximab and ofatumumab.
Van Berkel teaches on the subject of conjugates of an anti-CD19 antibody with PBD dimers (Van Berkel, Abstract). Van Berkel teaches “compound E” of Van Berkel, which is the same as the drug-linker-crosslinker moiety as ADCX19 as disclosed in the instant Specification (Van Berkel, p 11, line 4) that is conjugated to antibody RB4v1.2 of Van Berkel, which comprises VH and VL of Van Berkel’s SEQ ID NOs: 2 and 8, respectively (same as instant SEQ ID NOs: 2 and 8, respectively) (Van Berkel, p 168, lines 16-25). Van Berkel teaches that the conjugates of Van Berkel are administered in the treatment of proliferative diseases (Van Berkel, p 81, lines 21-24) including DLBCL (Van Berkel, p 82, lines 13-17). Van Berkel teaches that the diseases treated by the conjugates of Van Berkel are characterized by the overexpression of the target antigen (same as CD19+) (Van Berkel, p 82, lines 19-24). Van Berkel teaches that the conjugates of Van Berkel are administered in combination with other treatments, including the administration of chemotherapeutic agents (Van Berkel, p 84, lines 4-15), with Van Berkel’s definition of “chemotherapeutic agent” including the therapeutic antibodies rituximab and ofatumumab (Van Berkel, p 87, lines 1-7), either simultaneously or sequentially (Van Berkel, p 84, line 4-6).
It would be prima facie obvious to one of ordinary skill in the art to combine the ADC of the ‘584 patent with the rituximab and ofatumumab Van Berkel to form a method of treating relapsed or refractory DBLCL, said method comprising administering the ADC of the ‘584 patent in conjunction with rituximab and ofatumumab. One of ordinary skill in the art would be motivated to do this in order to better treat DBLCL. Van Berkel teaches administration of the ADCs of the ‘584 patent for DBLCL as well as further administration of rituximab and ofatumumab. The combination of the ADC of the ‘584 patent with ibrutinib for treating DBLCL is an obvious combination by virtue of the fact that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose… the idea of combining them flows logically from their having been individually taught in the prior art (see MPEP § 2144.06). In the instant case, Van Berkel teaches ADCx19 (identical to the reference ADC), rituximab and ofatumumab for DBLCL.
With respect to the “relapsed or refractory” limitation, the broadest reasonable limitation of “relapsed or refractory” would include DBLCL that is refractory to chemotherapeutics and one of ordinary skill would expect that the ADC of the ‘584 patent and the rituximab and ofatumumab of Van Berkel would not be impeded by the refractoriness of the cancers because antibody and antibody drug conjugate-based anti-cancer medications work via different mechanisms than chemotherapeutics.
Response to Arguments
Applicant supplied no arguments regarding this rejection specifically.
Conclusion
Claims 50, 53, 57-60, 62 and 64-66 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sydney Van Druff whose telephone number is (571)272-2085. The examiner can normally be reached 10 am - 6 pm.
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/SYDNEY VAN DRUFF/ Examiner, Art Unit 1643
/JULIE WU/ Supervisory Patent Examiner, Art Unit 1643