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 16-36 are pending and currently under consideration.
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.
Claims 16-22, 26-30, and 35 are rejected under 35 U.S.C. 103(a) as being unpatentable over Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65).
Skataric et al teaches simulations suggest that dosing regimen of the anti-CD20 drug ofatumumab for treating relapsing multiple sclerosis (RMS) in adults (loading doses + monthly 20 mg maintenance) is also suitable for children ˃10 years (Results and Conclusions, in particular).
Skataric et al does not specifically teach administering ofatumumab to a child having at most 40 kg body weight and/or aged between 5 to ˂18 years. However, these deficiencies are made up in the teachings of Hauser et al, Lee et al, and Pohl et al.
Hauser et al teaches therapeutically treating relapsed multiple sclerosis (RMS) adult patients comprising subcutaneously administering 20 mg doses of ofatumumab to the patients at days 1, 7, and 14 – followed by maintenance doses every 4 weeks (left column on page 548, right column on page 547, and Abstract, in particular). Hauser et al further teaches the maintenance doses are administered to maintain B-cell depletion (left column on page 556, in particular).
Lee et al teaches greater than 95% of pediatric multiple sclerosis patients show a relapse remitting (RRMS) course (left column on page 149, in particular). Lee et al further teaches pediatric multiple sclerosis patients include those whose weight is ˂40 kg (right column on page 151, in particular). Lee et al further teaches the youngest reported age of multiple sclerosis is 2 years and it is estimated that up to 10% of adults with multiple sclerosis have their first clinical event before the age of 18 (left column on page 148, in particular).
Pohl et al teaches some children with multiple sclerosis, including RRMS, have been treated with the multiple sclerosis therapies interferon beta and/or glatiramer acetate (Abstract, left column on page S56, and paragraph spanning columns of page S56, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating just any children ˃10 years at just any weight with relapsing multiple sclerosis (RMS), including RRMS that has been previously treated with any other multiple sclerosis therapy, by administering to the children the dosing regimen of ofatumumab for treating adults with RMS of Hauser et al (20 mg doses at days 1, 7, and 14 – followed by maintenance doses every 4 weeks) because Skataric et al teaches simulations suggest that dosing regimen of the anti-CD20 drug ofatumumab for treating relapsing multiple sclerosis (RMS) in adults (loading doses + monthly 20 mg maintenance) is also suitable for children ˃10 years (Results and Conclusions, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143.
Regarding “wherein the patient is switched to a dose of 20 mg every 4 weeks when the patient reaches a body weight of more than 40kg” of claim 29, patients of the combined method following the dosing regimen of Hauser et al that reach a body weight of more than 40kg and/or attain the age of 18 are administered doses of 20 mg every 4 weeks after the loading doses of the combined method because the dosing regimen of Hauser et al administers doses of 20 mg every 4 weeks after the loading doses.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 16-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65) as applied to claims 16-22, 26-30, and 35 above, and further in view of Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS).
Teachings of Skataric et al, Hauser et al, Lee et al, and Pohl et al are discussed above.
Skataric et al, Hauser et al, Lee et al, and Pohl et al do not specifically teach administering ofatumumab maintenance doses every six weeks. However, these deficiencies are made up in the teachings of Kurrasch et al.
Kurrasch et al teaches patients administered subcutaneous doses of ofatumumab resulted in depletion from 22 days to ˃85 days and most patients did not replete until at least day 43, which Kurrasch et al states suggests that monthly subcutaneous doses of ofatumumab may be sufficient to maintain depletion (paragraph spanning columns on page 1095, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to optimize the combined method wherein administered maintenance doses are administered less frequently (such as administering a maintenance dose starting at week 8 and continuing therefore every six weeks) in an effort to save money, time, and resources. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). Varying maintenance doses of ofatumumab to maintain B-cell depletion is a “result-effective” variable, as recognized by Hauser et al (left column on page 556, in particular) and Kurrasch et al (paragraph spanning columns on page 1095, in particular). Further, starting maintenance doses at week 8 and continuing therefore every six weeks should be sufficient to maintain depletion because Kurrasch et al teaches patients administered subcutaneous doses of ofatumumab resulted in depletion from 22 days to ˃85 days and most patients did not replete until at least day 43 (paragraph spanning columns on page 1095, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Claim Rejections - 35 USC § 103
Claim(s) 16-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallstrom et al (WO 2018/033841 A1; 2/2/18; 6/12/24 IDS) in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS), Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS).
Wallstrom et al teaches treating a subject with multiple sclerosis comprising administering ofatumumab to the subject (Abstract, in particular).
The instant claims differ from the teachings of Wallstrom et al in that the instant claims specify the subject has at most 40 kg body weight and/or is aged between 5 and ˂18 years. Some instant claims also specify maintenance doses not taught by Wallstrom et al. However, these deficiencies are made up in the teachings of Skataric et al, Hauser et al, Lee et al, and Pohl et al, and Kurrasch et al.
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating subjects with multiple sclerosis comprising administering ofatumumab to the subjects wherein the subject are just any children ˃10 years at just any weight with relapsing multiple sclerosis (RMS), including RRMS that has been previously treated with any other multiple sclerosis therapy, by administering to the children the dosing regimen of ofatumumab for treating adults with RMS of Hauser et al (20 mg doses at days 1, 7, and 14 – followed by maintenance doses every 4 weeks) because Skataric et al teaches simulations suggest that dosing regimen of the anti-CD20 drug ofatumumab for treating relapsing multiple sclerosis (RMS) in adults (loading doses + monthly 20 mg maintenance) is also suitable for children ˃10 years (Results and Conclusions, in particular). This is an example of some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to optimize the combined method wherein administered maintenance doses are administered less frequently (such as administering a maintenance dose starting at week 8 and continuing therefore every six weeks) in an effort to save money, time, and resources. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). Varying maintenance doses of ofatumumab to maintain B-cell depletion is a “result-effective” variable, as recognized by Hauser et al (left column on page 556, in particular) and Kurrasch et al (paragraph spanning columns on page 1095, in particular). Further, starting maintenance doses at week 8 and continuing therefore every six weeks should be sufficient to maintain depletion because Kurrasch et al teaches patients administered subcutaneous doses of ofatumumab resulted in depletion from 22 days to ˃85 days and most patients did not replete until at least day 43 (paragraph spanning columns on page 1095, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
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 16-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
the allowed claims of U.S. Patent No. 11161909 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS);
the allowed claims of U.S. Patent No. 12338290 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS);
the allowed claims of U.S. Patent No. 12570754 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS); and
the allowed claims of U.S. Patent No. 12723096 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS).
Both the instant claims and the patent claims are drawn to methods of treating multiple sclerosis comprising administering ofatumumab to a patient. The instant claims differ from the patent claims in that the instant claims specify the patient has at most 40 kg body weight and/or is aged between 5 and ˂18 years. Some instant claims also specify maintenance doses not recited by patent claims.
However, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating just any children ˃10 years at just any weight with relapsing multiple sclerosis (RMS), including RRMS that has been previously treated with any other multiple sclerosis therapy, by administering to the children ofatumumab of the patent claims wherein the dosing regimen is that of ofatumumab for treating adults with RMS of Hauser et al (20 mg doses at days 1, 7, and 14 – followed by maintenance doses every 4 weeks) because Skataric et al teaches simulations suggest that dosing regimen of the anti-CD20 drug ofatumumab for treating relapsing multiple sclerosis (RMS) in adults (loading doses + monthly 20 mg maintenance) is also suitable for children ˃10 years (Results and Conclusions, in particular).
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to optimize the combined method wherein administered maintenance doses are administered less frequently (such as administering a maintenance dose starting at week 8 and continuing therefore every six weeks) in an effort to save money, time, and resources. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). Varying maintenance doses of ofatumumab to maintain B-cell depletion is a “result-effective” variable, as recognized by Hauser et al (left column on page 556, in particular) and Kurrasch et al (paragraph spanning columns on page 1095, in particular). Further, starting maintenance doses at week 8 and continuing therefore every six weeks should be sufficient to maintain depletion because Kurrasch et al teaches patients administered subcutaneous doses of ofatumumab resulted in depletion from 22 days to ˃85 days and most patients did not replete until at least day 43 (paragraph spanning columns on page 1095, in particular).
Double Patenting
Claims 16-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
the pending claims of 17/753632 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS);
the pending claims of 17/995820 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS);
the pending claims of 17/753635 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS);
the pending claims of 18/286030 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS); and
the pending claims of 19/677438 in view of Skataric et al (J Pharmacokinet Pharmacodyn, 2018, 45: S3-S134, S86, T-090; 6/12/24 IDS) in view of Hauser et al (NEJM, 2020, 383(6): 546-557; 6/12/24 IDS), Lee et al (Pediatric Multiple Sclerosis, 2016, 36: 148-153), and Pohl et al (Neurology, 2007, 68(Suppl 2): S54-S65), and Kurrasch et al (The Journal of Rheumatology, 2013, 40(7): 1089-1096; 6/12/24 IDS).
Both the instant claims and the copending claims are drawn to methods of treating multiple sclerosis comprising administering ofatumumab to a patient. The instant claims differ from the copending claims in that the instant claims specify the patient has at most 40 kg body weight and/or is aged between 5 and ˂18 years. Some instant claims also specify maintenance doses not recited by copending claims.
However, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of treating just any children ˃10 years at just any weight with relapsing multiple sclerosis (RMS), including RRMS that has been previously treated with any other multiple sclerosis therapy, by administering to the children ofatumumab of the copending claims wherein the dosing regimen is that of ofatumumab for treating adults with RMS of Hauser et al (20 mg doses at days 1, 7, and 14 – followed by maintenance doses every 4 weeks) because Skataric et al teaches simulations suggest that dosing regimen of the anti-CD20 drug ofatumumab for treating relapsing multiple sclerosis (RMS) in adults (loading doses + monthly 20 mg maintenance) is also suitable for children ˃10 years (Results and Conclusions, in particular).
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to optimize the combined method wherein administered maintenance doses are administered less frequently (such as administering a maintenance dose starting at week 8 and continuing therefore every six weeks) in an effort to save money, time, and resources. “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Citing In re Dreyfus, 73 F.2d 931 (CCPA 1934); In re Waite, 168 F.2d 104 (CCPA 1948)). Varying maintenance doses of ofatumumab to maintain B-cell depletion is a “result-effective” variable, as recognized by Hauser et al (left column on page 556, in particular) and Kurrasch et al (paragraph spanning columns on page 1095, in particular). Further, starting maintenance doses at week 8 and continuing therefore every six weeks should be sufficient to maintain depletion because Kurrasch et al teaches patients administered subcutaneous doses of ofatumumab resulted in depletion from 22 days to ˃85 days and most patients did not replete until at least day 43 (paragraph spanning columns on page 1095, in particular).
This is provisional nonstatutory double patenting.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642
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