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
Response to Amendment
The Information Disclosure Statement (IDS) filed 19 May 2026 has been entered. Applicant’s amendment of the claims filed 19 May 2026 has been entered. Applicant’s remarks filed 19 May 2026 are acknowledged.
Claims 1-16, 18-19 and 37-54 are cancelled. Claims 17, 20-36 and 55-56 are pending and under examination to the extent they read on the elected species: B-a) wherein anifrolumab or the functional variant thereof is administered intravenously; and C) wherein the patient has received prior treatment with azathioprine.
Claim Objections/Rejections Withdrawn
The objection to claims 17 and 26-27 for using acronyms (e.g., “SLE”) without first defining what they represent in the independent claims is withdrawn in response to Applicant’s amendment of independent claim 17.
The objections to claims 20, 22-24 and 36 for various informalities are withdrawn in response to Applicant’s amendment of the claims.
The rejection of claim 17 and 29 under 35 U.S.C. 112(b), as being unclear whether the claims are limited to only IFNAR1 chain or the whole type I IFN receptor (IFNAR), is withdrawn in response to Applicant’s amendment of claim 17 to specify “wherein the type I IFN receptor inhibitor comprises …”.
The rejections of claims 33-35 under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, are withdrawn in response to Applicant’s amendment of claims.
The rejections of claims 17, 20-29, 33-36 and 55-56 under 35 U.S.C. 112(a), as failing to comply with the written description requirement, is withdrawn in response to Applicant’s amendment of independent claim 17 to limit wherein the type I IFN receptor inhibitor comprises three heavy chain and three light chain CDR sequences.
The provisional nonstatutory double patenting rejection over: 3) claims 65, 68-74 and 76 of Application No. 17/755,801, is withdrawn in view that the ‘801 application is now abandoned.
Claim Rejections Maintained
Claim Rejections - 35 USC § 102
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.
Claims 17, 20-34, 36 and 55-56 remain rejected under 35 U.S.C. 102(a)(1), as being anticipated by Furie et al. (Arthritis Rheumatol., 2017, Vol. 69(2):376-386).
Ground of Rejection
Furie teaches administering anifrolumab, a type I interferon (IFN) receptor antagonist, to treat patients with moderate-to-severe systemic lupus erythematosus (SLE), wherein the patients received intravenous anifrolumab at a dose of 300 mg or 1,000 mg, every 4 weeks for 48 weeks (see Abstract). Furie teaches that the patients had prior treatment with glucocorticoids (e.g., methotrexate), antimalarials and/or immunosuppressants (p. 379, Table 1). The patients of Furie, who had moderate-to-severe SLE despite prior treatment, meet the limitation as having treatment-refractory SLE. Furie teaches that the patients had low C3 and/or C4 complement at baseline (p. 379, Table 1), and a score of ≥6 on the SLE Disease Activity Index 2000 (SLEDAI-2K) (p. 377, col. 2, 3rd paragraph under “PATIENTS AND METHODS”). Furie teaches that the patients had a CLASI score of ≥10 at baseline, and the treatment led to a ≥50% reduction in the CLASI score by at least week 12 of treatment, which was maintained by week 52 (p. 380, Table 2; p. 382, col. 2, last paragraph; and p. 383, Figure 3). Furie teaches that the efficacy of treatment is assessed by determining, e.g., response in BICLA (p. 380, Table 2). Furie teaches that the use of oral corticosteroids was spared or tapered during the treatment (p. 378, col. 1, 1st full paragraph). Regarding claim 28, which recites “wherein the method has been demonstrated in a phase III clinical trial”, the claim does not have a patentable weight because there is no difference in the method taught by Furie and that claimed in the instant application. Therefore, Furie anticipates the instant claims.
Response to Applicant’s Arguments
Applicant argues that Furie fails to disclose wherein the patient has treatment-refractory SLE, and wherein the method reduces SLE disease activity in the patient.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
Furie teaches administration of anifrolumab to treat patients with moderate-to-severe SLE, wherein the patients had prior treatment with glucocorticoids (e.g., methotrexate), antimalarials and/or immunosuppressants, and Furie showed that the treatment was effective for the patients. The patients of Furie, who had moderate-to-severe SLE despite prior treatment, meet the limitation as having treatment-refractory SLE. Thus, Furie teaches treating the presently claimed patient population.
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.
Claim 35 remains rejected under 35 U.S.C. 103 as being unpatentable over Furie et al. (cited above), as applied to claims 17, 20-34, 36 and 55-56 above, and further in view of Higgs et al. (US 2015/0158949 A1, Pub. Date: Jun. 11, 2015).
Ground of Rejection
Furie teaches as set forth above. Furie, however, does not teach administering anifrolumab or the functional variant thereof at a dose of 120 mg every week (claim 35).
Higgs teaches a method of treating a type I IFN-mediated disease or disorder, such as systemic lupus erythematosus (SLE), in a patient comprising administering to the patient at least one intravenous or subcutaneous fixed dose of an anti-IFNAR antibody, such as MEDI-546 (anifrolumab) [0124]. Higgs teachs that MEDI-546 may be administered subcutaneously at a fixed dose of about 100 mg, and the doses can be administered approximately every week [0117-0119].
While Higgs does not teach administering anifrolumab at a dose of 120 mg every week, given that the level of skill in this art is very high, and that optimizing parameters such as the dose and administration frequency of a therapeutic agent is routine, modifying the dose of anifrolumab used by Furie in view of the teachings of Higgs to arrive at the claimed dose (e.g., 120 mg every week) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, with a reasonable expectation of success, absent evidence of unexpected results. As was found in In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), where 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.
Response to Applicant’s Arguments
Applicant argues that the combination of Furie and Higgs would not provide one of skill in the art with a reasonable expectation of success because the cited references fail to specifically disclose administering anifrolumab to a particularly challenging sub-group of patients who have already failed to respond to standard of care (SOC) treatments, i.e. glucocorticoids, antimalarials and immunosuppressants. Applicant argues that it was surprising and unexpected that administration of anifrolumab to patients with treatment-refractory SLE would be successful for this sub-group of patients. Applicant further argues that the specification shows in Figure 20 that anifrolumab had an effect on the subgroup of patients with treatment refractory disease as compared to placebo. Applicant also cites post-filing reference (Tani et al. (2024) and Plüß et al. (2022)) as support for the unexpected results of the efficacy of anifrolumab in treatment of refractory lupus.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
As set forth above (the 35 U.S.C. 102 section), Furie teaches administration of anifrolumab to treat patients with moderate-to-severe SLE, wherein the patients had prior treatment with glucocorticoids, antimalarials and/or immunosuppressants (i.e., patinets with treatment-refractory SLE). Unexpected results cannot overcome an anticipation rejection under 35 U.S.C. 102. Further, neither the specification (e.g., Figure 20), nor the post-filing references cited by Applicant, discloses administering anifrolumab at a dose of 120 mg every week to treat the disease. The results shown in Figure 20 of the specification, as well as in Plüß et al. (2022), were from administering 300 mg every 4 weeks by intravenous route, and no specific dosage of anifrolumab is disclosed in Tani et al. (2024). There is no evidence of unexpected results for “administering anifrolumab or the functional variant thereof to the patient at a dose of 120 mg every week, optionally wherein anifrolumab or the functional variant thereof is administered subcutaneously” as recited in claim 35, which is subjected to the obviousness rejection. Therefore, the rejection is maintained.
Double Patenting
Claims 17, 20-36 and 55-56 remain rejected on the ground of nonstatutory double patenting as being unpatentable over:
1) claims 1-5 and 10 of U.S. Patent No. 12,060,429; and
2) claims 1-4, 6-8 and 11 of U.S. Patent No. 12,410,254.
Applicant argues that the claims and disclosures of the '429 and ‘254 patents do not make the presently claimed method obvious, and there would be no reasonable expectation of success in treating the highly refractory patient population as claimed. Applicant argues that it was surprising and unexpected to observe that anifrolumab had an effect on a subgroup of patients who have previously failed to respond to SOC.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
The claims of the ‘429 and ‘254 patents recite a method of treating systemic lupus erythematosus (SLE) in a patient comprising administering to the patient anifrolumab (a type I IFN receptor inhibitor). The claims of the ‘429 and ‘254 patents differ from the instant claims in that the instant claims recite wherein the patient has treatment-refractory SLE. However, Furie (cited above) renders treating this subgroup of patients obvious. Furie teaches that administration of anifrolumab was effective in treating patients with treatment-refractory, moderate-to-severe SLE. It would have been prima facie obvious to one ordinary skill in the art to use the method claimed in the ‘429 and ‘254 patents to treat a patient having treatment-refractory, moderate-to-severe SLE. One of ordinary skill in the art would have been motivated to do so and have a reasonable expectation of success, because Furie teaches that the method claimed in the ‘429 and ‘254 patents was effective in treating a patient having moderate-to-severe and treatment-refractory SLE. Therefore, the claims of the ‘429 and ‘254 patents render the instant claims obvious in view of Furie.
Claims 17, 20-36 and 55-56 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
4) claims 20-22 and 33-46 of copending Application No. 18/291,671;
5) claims 67-70 of copending Application No. 18/435,476;
6) claims 67-70 of copending Application No. 18/474,601;
7) claims 1, 46-51, 53, 55 and 57 of copending Application No. 18/559,907; and
8) claims 11-18, 20, 27-28, 34-40 and 53 of copending Application No. 18/698,343.
The claims of each of the above cited copending applications recite a method of treating systemic lupus erythematosus (SLE) in a patient comprising administering to the patient anifrolumab (a type I IFN receptor inhibitor). The claims of each of the above cited copending applications differ from the instant claims in that the instant claims recite wherein the patient has treatment-refractory SLE. However, Furie (cited above) renders treating this subgroup of patients obvious. Furie teaches that administration of anifrolumab was effective in treating patients with treatment-refractory, moderate-to-severe SLE. It would have been prima facie obvious to one ordinary skill in the art to use the method claimed in the above cited copending applications to treat a patient having treatment-refractory, moderate-to-severe SLE. One of ordinary skill in the art would have been motivated to do so and have a reasonable expectation of success, because Furie teaches that the method claimed in the above cited copending applications was effective in treating a patient having moderate-to-severe and treatment-refractory SLE. Therefore, the claims of each of the above cited copending applications render the instant claims obvious in view of Furie.
In the response received on 19 May 2026, Applicant requests that the above provisional nonstatutory double patenting rejections be held in abeyance and Applicant will address these grounds of rejections upon notification that the instant claims are otherwise in condition for allowance.
Conclusion
NO CLAIM IS ALLOWED.
THIS ACTION IS MADE FINAL. 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 Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674
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