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
Priority
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. Claims 8, 11-22, and 24-40 have an effective filing date of 28MAR2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 8/9/2024 Applicant elected, without traverse:
A distinct pharmaceutical composition with dosage, frequency, route, and duration of administration
pharmaceutical composition with dosage of:
about 1,800 mg of said antibody and about 30,000 U rHuPH20;
about 4 mg of pomalidomide;
about 40 mg of dexamethasone
a frequency of:
antibody and rHuPH20: once a week;
pomalidomide: once daily;
dexamethasone: once a week;
a route of:
antibody and rHuPH20: subcutaneously;
pomalidomide: orally;
dexamethasone: orally or intravenously
a duration of: one or more 28-day cycles
A distinct excipient
10 mM of the excipient histidine
Status of Claims
Claims 8, 11-22, and 24-40 are currently pending and presented for examination on the merits.
Claims 16, 18-22, and 34 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 8, 11-12, 14, 24-31, and 35-40 are amended.
Claims 1-7, 9-10, and 23 are canceled.
Rejections Withdrawn
The rejections filed under Double Patenting are withdrawn in view of case abandonment.
Rejections Maintained
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.
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 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 8, 11-15, 24, 26-28, 35, 37, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al (DARZALEX® ( daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies, June 2017), Elias et al (WO 2012092616 A1, IDS), San-Miguel et al (Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO), PF555, 2018, IDS), and further in view of Richardson et al (Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study, Blood, Vol. 123, number 12, 2014).
In regards to claims 8, and 26-27, Janssen Biotech teaches a method of treating multiple myeloma [1st Paragraph, pg. 1]. Janssen Biotech further teaches treating multiple myeloma by administering daratumumab in combination with pomalidomide and dexamethasone [1st Paragraph, pg.1]. Janssen Biotech further teaches the combination of daratumumab, pomalidomide, and dexamethasone [1st Paragraph, pg. 1]. Janssen Biotech further teaches daratumumab is an anti-CD38 antibody [2nd Paragraph, pg. 1].
Jansson et al does not specifically teach an antibody that binds CD38 comprising SEQ ID NOs: 7 and 8, and subcutaneous administration. However, this deficiency is made up in the teachings of Elias et al.
In regards to claim 23, Elias et al teaches an anti-CD-38 antibody comprising SEQ ID NO:24. A comparison of instant SEQ ID NO: 7 and SEQ ID NO: 24 of Elias et al is shown below.
Elias et al SEQ ID NO: 7 and SEQ ID NO: 24 of Elias et al.
Query Match 100.0%; Score 643; Length 122;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYY 60
Qy 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTV 120
Qy 121 SS 122
||
Db 121 SS 122
Elias et al teaches an anti-CD-38 antibody comprising SEQ ID NO:25. A comparison of instant SEQ ID NO: 8 and SEQ ID NO: 25 of Elias et al is shown below.
Elias et al SEQ ID NO: 8 and SEQ ID NO: 25 of Elias et al.
Query Match 100.0%; Score 556; Length 108;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIK 107
Elias et al further teaches administering the treatment subcutaneously [0249].
Jansson et al does not specifically teach recombinant human hyaluronidase (rHuPH20). However, this deficiency is made up in the teachings of San-Miguel.
San-Miguel et al teaches the use of a CD38-targeted antibody in combination with pomalidomide and dexamethasone [Introduction]. San-Miguel et al further teaches the combination of an anti-CD38 antibody and recombinant human hyaluronidase (rHuPH20) [Introduction]. San-Miguel et al further teaches treating multiple myeloma [Introduction].
Jansson et al does not specifically teach an improved ORR compared to a population having been administered pomalidomide and dexamethasone but not said pharmaceutical composition. However, this deficiency is made up in the teachings of Richardson et al.
Richardson et al teaches the treatment of multiple myeloma comprising administering pomalidomide and dexamethasone [Abstract]. Richardson et al further teaches administering pomalidomide and dexamethasone to multiple myeloma patients has an ORR of 33% [Table 2, pg. 1830].
One of ordinary skill, before the effective filing date, would be motivated to combine Jansson Biotech’s method of treating multiple myeloma comprising administering an anti-CD38 antibody(daratumumab) with pomalidomide and dexamethasone, with Elias’s method of treating multiple myeloma by administering anti-CD38 antibody comprising SEQ ID NOs: 7 and 8, with San-Miguel’s method of treating multiple myeloma using rHuPH20 and administering subcutaneously, with Richardson’s method of treating multiple myeloma by administering pomalidomide and dexamethasone alone and achieving an improvement in median progression free survival (PFS) in a subject or a population of subjects with multiple myeloma. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Jansson Biotech, Elias, San-Miguel, and Richardson’s teachings for a method of achieving an improvement in median progression free survival (PFS) in a subject or a population of subjects with multiple myeloma comprising subcutaneously administering a pharmaceutical composition comprising an anti-CD38 antibody and rHuPH20 along with pomalidomide and dexamethasone, because Jansson teaches the combination of daratumumab, pomalidomide, and dexamethasone achieving an improvement treatment.
In regards to claim 11, Elias et al teaches administering the treatment subcutaneously [0249].
In regards to claim 12, San-Miguel et al further teaches the administration of daratumumab at 1,800 mg and rHuPH20 at 30,000 U [Figure 3].
In regards to claim 13, San-Miguel et al further teaches administer the rHuPH20 30,000 U in a 15 mL dose, 2,000 U/mL [Methods].
In regards to claims 14-15, Elias et al further teaches administering an excipient with the formulation [0243]. Elias et al further teaches administering the excipient histidine [0243].
In regards to claim 24, Elias et al further teaches the antibody comprising the IgG1 isotype [0059].
In regards to claim 28, Elias et al further teaches administering the anti-CD38 antibody once a week, for up to 8 times [0267].
In regards to claim 35 and 37, Richardson et al further teaches pomalidomide administered orally [Left Column, Discussion, pg. 1830].
In regards to claims 39-40, Jansson Biotech further teaches the anti-CD38 antibody daratumumab is treatment for patients that are refractory [2nd Paragraph, pg. 1].
Claims 8, 11-15, 17, 24-28, 35, 37, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al (DARZALEX® ( daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies, June 2017), Elias et al (WO 2012092616 A1, IDS), San-Miguel et al (Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO), PF555, 2018, IDS), Richardson et al (Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study, Blood, Vol. 123, number 12, 2014) as applied to claims 8, 11-15, 24, 26-28, 35, 37, and 39-40 above, and further in view of Jansson et al (US 20170121414 A1).
The teachings of Jansson Biotech, Elias et al, San-Miguel et al, and Richardson et al are discussed above.
Jansson Biotech does not specifically teach 10 mM histidine and SEQ ID NOs: 9-10. However, this deficiency is made up in the teachings of Jansson et al.
In regards to claim 17, at [0015], Jansson et al teaches an antibody formulation comprising histidine at a concentration of 5-10 mM.
In regards to claim 25, Jansson et al teaches an anti-CD38 antibody comprising SEQ ID NO: 12. A comparison of instant SEQ ID NO: 9 and SEQ ID NO: 12 of Jansson et al is shown below.
Instant SEQ ID NO: 9 and SEQ ID NO: 12 of Jansson et al.
Query Match 100.0%; Score 2410; Length 452;
Best Local Similarity 100.0%;
Matches 452; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYY 60
Qy 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTV 120
Qy 121 SSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ 180
Qy 181 SSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELL 240
Qy 241 GGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQ 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQ 300
Qy 301 YNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSR 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSR 360
Qy 361 EEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKS 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 EEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKS 420
Qy 421 RWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 452
||||||||||||||||||||||||||||||||
Db 421 RWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 452
Jansson et al teaches an anti-CD38 antibody comprising SEQ ID NO: 13. A comparison of instant SEQ ID NO: 10 and SEQ ID NO: 13 of Jansson et al is shown below.
Instant SEQ ID NO: 10 and SEQ ID NO: 13 of Jansson et al.
Query Match 100.0%; Score 1109; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPA 60
Qy 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTDFTLTISSLEPEDFAVYYCQQRSNWPPTFGQGTKVEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
One of ordinary skill, before the effective filing date, would have been motivated to combine Janssen Biotech’s method of treating multiple myeloma comprising administering an anti-CD38 antibody(daratumumab) with pomalidomide and dexamethasone, with Elias’s method of treating multiple myeloma by administering anti-CD38 antibody comprising SEQ ID NOs: 7 and 8, with San-Miguel’s method of treating multiple myeloma using rHuPH20 and administering subcutaneously, with Richardson’s method of treating multiple myeloma by administering pomalidomide and dexamethasone alone and achieving an ORR of 33%, with Jansson’s method of treating multiple myeloma comprising an anti-CD38 antibody comprising SEQ ID NOs: 9-10. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Jansson Biotech, Elias, San-Miguel, Richardson, and Jansson’s teachings for a method of achieving an improvement in median progression free survival (PFS) in a subject or a population of subjects with multiple myeloma comprising subcutaneously administering a pharmaceutical composition comprising an anti-CD38 antibody and rHuPH20 along with pomalidomide and dexamethasone, because Jansson teaches the combination of daratumumab, pomalidomide, and dexamethasone achieving an improvement treatment.
Claims 8, 11-15,24, 26-33, 35, 37, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al (DARZALEX® ( daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies, June 2017), Elias et al (WO 2012092616 A1, IDS), San-Miguel et al (Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO), PF555, 2018, IDS), Richardson et al (Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study, Blood, Vol. 123, number 12, 2014) as applied to claims 8, 11-15, 24, 26-28, 35, 37, and 39-40 above, and further in view of Zander et al (Spotlight on pomalidomide: could less be more?, Leukemia, 31, 1987-2008, 2017, Previous OA).
The teachings of Jansson Biotech, Elias et al, San-Miguel et al, and Richardson et al are discussed above.
Jansson Biotech does not specifically teach dosage and frequency for pomalidomide and dexamethasone. However, this deficiency is made up in the teachings of Zander et al.
In regards to claims 29 and 30-33, Zander et al teaches the treatment of relapsed or refractory multiple myeloma [Left column, 2nd paragraph, pg. 1987]. Zander et al further teaches treating multiple myeloma with pomalidomide and dexamethasone [Left column, 2nd paragraph, pg. 1987]. Zander et al further teaches administering pomalidomide at 4 mg per day d1-d21 for a 28 day cycle [Left column, 2nd paragraph, pg. 1987].
In regards to claim 30, Zander et al further teaches administering dexamethasone at 40 mg weekly [Right column, 3rd paragraph, pg. 1987].
One of ordinary skill, before the effective filing date, would have been motivated to combine Janssen Biotech’s method of treating multiple myeloma comprising administering an anti-CD38 antibody(daratumumab) with pomalidomide and dexamethasone, with Elias’s method of treating multiple myeloma by administering anti-CD38 antibody comprising SEQ ID NOs: 7 and 8, with San-Miguel’s method of treating multiple myeloma using rHuPH20 and administering subcutaneously, with Richardson’s method of treating multiple myeloma by administering pomalidomide and dexamethasone alone, with Zander’s method of treating multiple myeloma comprising administering dexamethasone at 40 mg weekly and pomalidomide at 4 mg daily for days 1-21 of a 28 day cycle. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Jansson Biotech, Elias, San-Miguel, Richardson, and Zander’s teachings for a method of improving ORR in a subject with multiple myeloma comprising subcutaneously administering a pharmaceutical composition comprising an anti-CD38 antibody and rHuPH20 along with pomalidomide and dexamethasone, because Jansson teaches the combination of daratumumab, pomalidomide, and dexamethasone achieving an improvement treatment.
Claims 8, 11-15, 24, 26-28, and 35-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al (DARZALEX® ( daratumumab) Approved by the U.S. FDA in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Who Have Received At Least Two Prior Therapies, June 2017), Elias et al (WO 2012092616 A1, IDS), San-Miguel et al (Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO), PF555, 2018, IDS), Richardson et al (Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study, Blood, Vol. 123, number 12, 2014) as applied to claims 8, 11-15, 24, 26-28, 35, 37, and 39-40 above, and further in view of LeClair et al (US 20190048091 A1).
The teachings of Jansson Biotech, Elias et al, San-Miguel et al, and Richardson et al are discussed above.
Jansson Biotech does not specifically teach the dexamethasone self-administered or administered intravenously, or orally. However, this deficiency is made up in the teachings of LeClair et al.
In regards to claims 36 and 38, LeClair et al teaches treatments for multiple myeloma [Abstract]. LeClair et al further teaches the treatment of pomalidomide and dexamethasone [0073]. LeClair et al further teaches the dexamethasone is administered orally [0082].
One of ordinary skill, before the effective filing date, would have been motivated to combine Janssen Biotech’s method of treating multiple myeloma comprising administering an anti-CD38 antibody(daratumumab) with pomalidomide and dexamethasone, with Elias’s method of treating multiple myeloma by administering anti-CD38 antibody comprising SEQ ID NOs: 7 and 8, with San-Miguel’s method of treating multiple myeloma using rHuPH20 and administering subcutaneously, with Richardson’s method of treating multiple myeloma by administering pomalidomide and dexamethasone alone and achieving an ORR of 33%, with LeClair’s method of treating multiple myeloma comprising dexamethasone administered orally. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Jansson Biotech, Elias, San-Miguel, Richardson, and LeClair’s teachings for a method of improving ORR in a subject with multiple myeloma comprising subcutaneously administering a pharmaceutical composition comprising an anti-CD38 antibody and rHuPH20 along with pomalidomide and dexamethasone, because Jansson teaches the combination of daratumumab, pomalidomide, and dexamethasone achieving an improvement treatment.
Applicant’s Arguments:
The cited references do not teach or suggest the claimed therapy
Even if the skilled person had chosen to investigate subcutaneous administration of daratumumab with rHuPH2O in combination with pomalidomide and dexamethasone, they still would not have had an expectation of successfully achieving an improvement in PFS because the EQUULEUS study is an early-stage, Phase lb trial designed to evaluate safety and tolerability of daratumumab, and not a late-stage trial set up to detect a meaningful effect on clinical outcomes such as PFS.
Those of skill in the art would have no reasonable expectation of success in achieving the claimed improvement in median PFS
one of skill in the art would still lack a reasonable expectation of success in achieving the claimed improvement in PFS
The Claimed Therapy Provides Unexpected Results
surprisingly and unexpectedly revealed an improvement in median PFS of 12.4 months for subjects who were administered the pharmaceutical composition with pomalidomide and dexamethasone versus only 6.9 months for subjects who were administered pomalidomide and dexamethasone alone.
Examiner’s Response:
One of ordinary skill, before the effective filing date, would be motivated to combine Jansson Biotech’s method of treating multiple myeloma comprising administering an anti-CD38 antibody(daratumumab) with pomalidomide and dexamethasone, with Elias’s method of treating multiple myeloma by administering anti-CD38 antibody comprising SEQ ID NOs: 7 and 8, with San-Miguel’s method of treating multiple myeloma using rHuPH20 and administering subcutaneously, with Richardson’s method of treating multiple myeloma by administering pomalidomide and dexamethasone alone and achieving an improvement in median progression free survival (PFS) in a subject or a population of subjects with multiple myeloma. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Jansson Biotech, Elias, San-Miguel, and Richardson’s teachings for a method of achieving an improvement in median progression free survival (PFS) in a subject or a population of subjects with multiple myeloma comprising subcutaneously administering a pharmaceutical composition comprising an anti-CD38 antibody and rHuPH20 along with pomalidomide and dexamethasone, because Jansson teaches the combination of daratumumab, pomalidomide, and dexamethasone achieving an improvement treatment.
Furthermore, one of ordinary skill in the art would have been motivated to improve median PFS in a subject or a population with multiple myeloma, because Stenger et al teaches the addition of daratumumab to multiple myeloma combination treatment achieving median PFS at 12 months was 12.3 months vs 7.2 months without daratumumab.
Applicant’s unexpected results exhibit a similar trend with just the addition of daratumumab.
Conclusion
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 DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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