DETAILED ACTION
Claims 11-18, 20, 27-28, 34-40, and 53 are pending in the instant application and being examined on the merit.
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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claims 11-13, 17-18, 20, 27-28, and 34-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morand et al (“Trial of Anifrolumab in Active Systemic Lupus Erythematosus”, N Engl J Med, December 18, 2019, 382:211-221), hereinafter Morand.
Regarding instant claims 11-13, Morand teaches administering to a human subject who has systemic lupus erythematosus (SLE) a therapeutically effective amount of anifrolumab, a human monoclonal antibody to type I interferon receptor subunit 1, wherein the subjects were evaluated by SLEDAI-2K and BILAG-2004, well-known instruments that score painful disease manifestations, including lupus headache, arthritis and serositis (page 211, Abstract; page 212, left column, second paragraph; page 213, §Trial Procedures and §End Points).
Regarding instant claims 17-18 and 28, Morand teaches two phase 3 clinical trials of anifrolumab (TULIP-1 and TULIP-2), wherein both clinical trials resulted in favoring anifrolumab treatment, wherein the subjects on anifrolumab had a BICLA response, thus showing reduced SLE disease activity (page 212, left column, second paragraph; Figure 2)
Regarding instant claim 20, Morand teaches steroid sparing in the subject wherein for subjects who received oral prednisone or equivalent at a dose of 10mg or more per day (pre-sparing dose), an attempt at tapering to 7.5mg or less per day (post-sparing dose) was required between weeks 8 and 40 (page 213, §Trial Procedures).
Regarding instant claim 27, Morand discloses that the subjects had moderate-to-severe SLE (page 211, Abstract; page 212-213, §Entry Criteria).
Regarding instant claims 34-38, Morand discloses administering anifrolumab to SLE patients at a fixed dose of 300 mg intravenously every four weeks (page 211, Abstract; page 213, §Trial Procedures).
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.
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 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Morand et al (“Trial of Anifrolumab in Active Systemic Lupus Erythematosus”, N Engl J Med, December 18, 2019, 382:211-221), hereinafter Morand, as applied to claim 11 above, and further in view of Furie et al (“Anifrolumab, an Anti-Interferon-α Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus”, Arthritis & Rheumatology, February 2017, 69(2):376-386), hereinafter Furie, and Cojocaru et al (“Manifestations of Systemic Lupus Erythematosus”, Maedica (Bucur), October 2011, 6(4):330-336), hereinafter Cojocaru.
Regarding instant claims 14-16, the teachings of Morand are set forth above in the 102 rejections.
However, Morand does not teach that the treatment method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
The deficiency is resolved by Furie and Cojocaru.
Furie teaches administering 300mg of anifrolumab to patients with moderate-to-severe SLE, wherein secondary efficacy measures included Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) and the Short Form 36 (SF-36) health survey (page 376, Abstract-Methods; page 378, §Efficacy and Safety evaluations). Furie discloses that subjects who received anifrolumab resulted in a 3-point improvement from base line in the FACIT-F score, a 3.8-point improvement from base line in the SF-36 mental component summary (MCS), and a 3.1-point improvement from base line in the SF-36 physical component summary (PCS) compared to subjects in the placebo group (page 382, right column, last paragraph – page 383, left column, first paragraph; Table 2).
Cojocaru teaches that SLE is a chronic, multifaceted autoimmune inflammatory disease that can affect any part of the body with a variety of presenting features and manifestations (page 330, abstract). Cojocaru discloses that patients with SLE may present with various systemic manifestations, wherein the general symptoms include headache and fatigue, wherein fatigue is the most common constitutional symptom associated with SLE (page 331, left column, §Constitutional manifestations). Cojocaru also discloses that involvement of the musculoskeletal system is extremely common in patients with SLE, wherein patients most often seek medical attention for joint pain, with small joints of the hand and wrist usually affected, although any joint is at risk (page 331, right column, §Musculoskeletal manifestations). Cojocaru further discloses that neurological manifestations of lupus are reported in 25 to 75% of patients and can involve all parts of the nervous system, wherein headache and mood disorders may be the most commonly reported neurologic manifestation of SLE (page 332, right column, §Neuropsychiatric manifestations).
Regarding instant claims 14-16, it would have been obvious for a person having ordinary skill in the art at the time of filing to modify the method of administering to a human subject with SLE a therapeutically effective amount of anifrolumab of Morand to include measuring FACIT-F and SF-36 in both treatment groups to show the differences in these measurements between the anifrolumab and placebo groups as taught by Furie since constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders) are common in SLE patients as taught by Cojocaru. This is obvious because, Morand teaches administering to a human subject with SLE a therapeutically effective amount of anifrolumab, Furie teaches subjects who received anifrolumab resulted in improvements from base line in the FACIT-F score, SF-36 MCS, and SF-36 PCS compared to subjects in the placebo group , and Cojocaru teaches that SLE is a chronic, multifaceted autoimmune inflammatory disease that can affect any part of the body with a variety of presenting features and manifestations, such as constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders). Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to form the instant method of treating pain in a subject in need thereof comprising administering to the subject a therapeutically effective amount of anifrolumab, wherein the subject has SLE, and wherein the instant method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
Claims 39-40 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Morand et al (“Trial of Anifrolumab in Active Systemic Lupus Erythematosus”, N Engl J Med, December 18, 2019, 382:211-221), hereinafter Morand, as applied to claim 11 above, and further in view of Higgs et al (US20150158949A1, Priority to June 13, 2012, Published on June 11, 2015).
Regarding instant claims 39-40 and 53, the teachings of Morand are set forth above in the 102 rejections.
However, Morand does not teach the treatment method comprising administering anifrolumab subcutaneously to the patient at a dose of about 120mg per week.
The deficiency is resolved by Higgs.
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) (page 36, ¶ [0124]). Higgs further teaches that MEDI-546 may be administered subcutaneously at a fixed dose of about 100 mg, and the doses can be administered approximately every week (page 35-36, ¶ [0117-0119]).
In regards to instant claims 39 and 40, 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 Morand 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.
Regarding instant claim 53, it would have been obvious for a person having ordinary skill in the art at the time of filing to modify the method of administering to a human subject with SLE 120mg every week of anifrolumab taught by the combined teachings of Morand and Higgs, to comprise administering anifrolumab subcutaneously as taught by Higgs. This is obvious because, the combined teachings of Morand and Higgs teach administering anifrolumab to a human subject with SLE at a fixed dose of about 120mg weekly, wherein the subjects were evaluated by SLEDAI-2K and BILAG-2004, well-known instruments that score painful disease manifestations, (e.g. lupus headache, arthritis and serositis), and Higgs teaches a method of treating a type I IFN-mediated disease or disorder, such as SLE, in a patient comprising administering to the patient at least one subcutaneous fixed dose of an anti-IFNAR antibody, such as MEDI-546 (anifrolumab). Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to form the instant method of treating pain in a subject in need thereof comprising subcutaneously administering to the subject a fixed dose of about 120mg per week, wherein the subject has SLE.
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 11, 27, 34, 39-40, and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 10 of U.S. Patent No. 12,060,429B2 (Lindholm et al, Priority to April 23, 2021, hereinafter ‘429) in view of Morand et al (“Trial of Anifrolumab in Active Systemic Lupus Erythematosus”, N Engl J Med, December 18, 2019, 382:211-221). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-5 and 10 of ‘429 are directed to a method of treating type I interferon (IFN)-mediated disease in a subject comprising subcutaneously administering a unit dose comprising 120mg of a type I interferon (IFN) receptor (IFNAR1) inhibitor, wherein: 1) the IFNAR1 inhibitor is anifrolumab; 2) the type 1 IFN-mediated disease is moderate to severe, active autoantibody-positive SLE; and 3) the unit dose is for subcutaneous injection once per week (QW) to the subject in need thereof.
‘429 does not teach a method of treating pain in a subject with SLE.
The deficiency is resolved by Morand.
The teachings of Morand are set forth above in the 103 rejection.
It would have been obvious for a person having ordinary skill in the art at the time of filing to modify the method of treating moderate-to-severe SLE in a subject comprising subcutaneously administering a unit dose comprising 120mg of anifrolumab once per week (QW) to the subject in need thereof of ‘429 to include treating as taught by Morand. This is obvious because, ‘429 teaches a method of treating moderate-to-severe SLE in a subject in need thereof comprising subcutaneously administering a unit dose comprising 120mg of anifrolumab once per week, and Morand teaches administering to a human subject who has SLE a therapeutically effective amount of anifrolumab, wherein the subjects were evaluated by SLEDAI-2K and BILAG-2004, well-known instruments that score painful disease manifestations, including lupus headache, arthritis and serositis. Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to form the instant method of treating pain in a subject in need thereof comprising administering to the subject anifrolumab at a dose of 120mg every week subcutaneously, wherein the subject has SLE. Therefore, the claims of the above cited patent render the instant claims obvious in view of Morand.
Claims 11-13, 20, 34-40, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9, 11, 28-30, 46, 51, 53, 55 and 57 of copending Application No. 18/559,907 (Abreu et al, Priority to May 12, 2021; hereinafter ‘907) and in further view of Morand et al (“Trial of Anifrolumab in Active Systemic Lupus Erythematosus”, N Engl J Med, December 18, 2019, 382:211-221) and Higgs et al (US20150158949A1, Priority to June 13, 2012, Published on June 11, 2015). Although the claims at issue are not identical, they are not patentably distinct from each other.
In regard to instant claims 11-13 and 20, claims 1-2, 9, 11, 28-30, 46 and 51 of ‘907 are directed to a method of treating SLE in a subject comprising a type I interferon (IFN) receptor (IFNAR1) inhibitor, anifrolumab, and a steroid wherein the pre-sparing dose of ≥10 mg/day prednisone administered to the subject is tapered to a post-sparing dose. Regarding instant claims 34-38 and 53, claims 53, 55, and 57 of ‘907 teach administering anifrolumab at a dose of about 300mg every four weeks, subcutaneously.
‘907 does not teach treating pain comprising administering anifrolumab in a subject in need thereof, wherein anifrolumab is administered intravenously at a dose of about 300mg every four weeks or subcutaneously at a dose of about 120mg every week.
The deficiency is resolved by Morand and Higgs.
The teachings of Morand and Higgs are set forth above in the 103 rejection.
It would have been obvious for a person having ordinary skill in the art at the time of filing to modify method of treating SLE in a subject comprising administering anifrolumab and a steroid wherein the pre-sparing dose of ≥10 mg/day prednisone administered to the subject is tapered to a post-sparing dose as taught by ‘907, to comprise treating pain administering anifrolumab subcutaneously at 120 mg every week as taught by Higgs or intravenously at 300mg every four weeks as taught by Morand. This is obvious because, ‘907 teaches a method of treating SLE in a subject comprising administering anifrolumab at 300mg every four weeks and a steroid, wherein the pre-sparing dose of ≥10 mg/day prednisone administered to the subject is tapered to a post-sparing dose, Morand discloses administering anifrolumab to SLE patients at a fixed dose of 300 mg intravenously every four weeks, and Higgs teaches a method of treating a type I IFN-mediated disease or disorder, such as SLE, in a patient comprising administering to the patient at least one subcutaneous fixed dose of an anti-IFNAR antibody, such as MEDI-546 (anifrolumab). Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to form the instant method of treating pain in a subject in need thereof comprising subcutaneously administering to the subject a fixed dose of about 120mg per week or intravenously administering to the subject a fixed dose of 300mg every four weeks, wherein the subject has SLE.
Therefore, the claims of the above copending application ‘907 render the instant claims obvious in view of Morand and Higgs. This is a provisional nonstatutory double patenting rejection.
Claims 11-18, 20, 27-28, and 34-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-12, 33-36, 40-42, 44-48, 53, 55, 63-64 of copending Application No. 17/755,801 (Berglind et al, Priority to November 11, 2019; hereinafter ‘801). Although the claims at issue are not identical, they are not patentably distinct from each other.
In regard to instant claims 11, 17 and 27-28, claims 1-2, 41-42, 45-47, 55 of ‘801 are directed to a method of treating SLE in a subject comprising administering a type I interferon (IFN) receptor (IFNAR1) inhibitor, anifrolumab, wherein anifrolumab reduces SLE disease activity in the subject and has been demonstrated in a phase III clinical trial. Regarding instant claims 12-16, 18, and 20, claims 3-7, 11-12, 33-36, 40, and 63-64 of ‘801 teaches that the method reduced SLE disease activity in the subject comprising a BICLA response and reducing the dose of prednisone administered to the subject compared to the dose administered pretreatment ( ≥10 mg/day) in the subject, wherein the BICLA response corresponds to an improvement in patient reported outcome (PRO) of treatment in the subject, wherein the PRO comprises the subject’s FACIT-F and SF36 scores. Regarding instant claims 34-38, claims 44, 48 and 53 of ‘801 recite that anifrolumab is administered at a dose of 300mg every 4 weeks intravenously. Therefore, the claims of ‘801 render the instant claims obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 11-13, 17, 20, 27-28, 34-40, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 27-36, 39-42, and 45 of copending Application No. 18/248,280 (Kalyani et al, Priority to October 8, 2020; hereinafter ‘280). Although the claims at issue are not identical, they are not patentably distinct from each other.
In regard to instant claims 11-13, 17 and 27-28, claims 1-2, 27-30, and 45 of ‘280 are directed to a method of treating SLE in a subject comprising administering a type I interferon (IFN) receptor (IFNAR1) inhibitor, anifrolumab, wherein anifrolumab reduces SLE disease activity in the subject and has been demonstrated in a phase III clinical trial. Regarding instant claims 20, claims 36, 39-42 of ‘280 teach that the method comprises steroid sparing in the subject, wherein the dose of prednisone administered to the subject is tapered from a pre-sparing dose to a post-sparing dose in the subject. Regarding instant claims 34-40 and 53, claims 31-35 of ‘280 recite that anifrolumab is administered at a dose of 300mg every 4 weeks intravenously or 120mg every week subcutaneously. Therefore, the claims of ‘280 render the instant claims obvious.
This is a provisional nonstatutory double patenting rejection.
Claims 11-16, 34, 39-40, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 67-70 of copending Application No. 18/435,476 (Streicher et al, Priority to April 23, 2021; hereinafter ‘476), and further in view of Furie et al (“Anifrolumab, an Anti-Interferon-α Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus”, Arthritis & Rheumatology, February 2017, 69(2):376-386), hereinafter Furie, and Cojocaru et al (“Manifestations of Systemic Lupus Erythematosus”, Maedica (Bucur), October 2011, 6(4):330-336), hereinafter Cojocaru. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 67 of ‘476 are directed to a method of treating a type I IFN mediated disease in a subject in need thereof, the method comprising subcutaneously administering a dose of >105mg and ≤150 mg anifrolumab to the subject. Claims 68-70 further limits the method to comprise subcutaneously administering a dose of 120mg anifrolumab to the subject once a week, wherein the type I IFN mediated disease is SLE.
However, 476 does not teach that the treatment method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
The deficiency is resolved by Furie and Cojocaru.
The teachings of Furie and Cojocaru are set forth above in the 103 rejection.
It would have been obvious for a person having ordinary skill in the art at the time of filing to modify the method of administering to a human subject with SLE a therapeutically effective amount of anifrolumab of ’476 to include measuring FACIT-F and SF-36 in anifrolumab and placebo groups as taught by Furie since constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders) are common in SLE patients as taught by Cojocaru. This is obvious because, ‘476 teaches administering to a human subject with SLE a therapeutically effective amount of anifrolumab, Furie teaches subjects who received anifrolumab resulted in improvements from base line in the FACIT-F score, SF-36 MCS, and SF-36 PCS compared to subjects in the placebo group, and Cojocaru teaches that SLE is a chronic, multifaceted autoimmune inflammatory disease that can affect any part of the body with a variety of presenting features and manifestations, such as constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders). Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to form the instant method of treating pain in a subject in need thereof comprising administering to the subject a therapeutically effective amount of anifrolumab, wherein the subject has SLE, and wherein the instant method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
Therefore, the claims of ‘476render the instant claims obvious in view of Furie and Cojocaru. This is a provisional nonstatutory double patenting rejection.
Claims 11-16, 27, 34-40, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 33-44 of copending Application No. 18/291,671 (Lindholm et al, Priority to July 27, 2021; hereinafter ‘671), and further in view of Furie et al (“Anifrolumab, an Anti-Interferon-α Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus”, Arthritis & Rheumatology, February 2017, 69(2):376-386), hereinafter Furie, and Cojocaru et al (“Manifestations of Systemic Lupus Erythematosus”, Maedica (Bucur), October 2011, 6(4):330-336), hereinafter Cojocaru. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 11 and 27, claim 20 of ‘671 recite a method of treating SLE in a subject in need thereof, the method comprising administering a pharmaceutical composition comprising anifrolumab to the subject wherein the subject has severe SLE. Regarding instant claims 34-40 and 53, claims 33-44 of ‘671 recite the said methos comprises administering the pharmaceutical composition comprising anifrolumab intravenously at a dose of 300mg every four weeks or subcutaneously at a dose of 120mg every week.
However, 671 does not teach that the treatment method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
The deficiency is resolved by Furie and Cojocaru.
The teachings of Furie and Cojocaru are set forth above in the 103 rejection.
It would have been obvious for a person having ordinary skill in the art at the time of filing to modify the method of administering to a human subject with SLE a therapeutically effective amount of anifrolumab of ‘671 to include measuring FACIT-F and SF-36 in anifrolumab and placebo groups as taught by Furie since constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders) are common in SLE patients as taught by Cojocaru. This is obvious because, ‘671 teaches administering to a human subject with SLE a therapeutically effective amount of anifrolumab, Furie teaches subjects who received anifrolumab resulted in improvements from base line in the FACIT-F score, SF-36 MCS, and SF-36 PCS compared to subjects in the placebo group, and Cojocaru teaches that SLE is a chronic, multifaceted autoimmune inflammatory disease that can affect any part of the body with a variety of presenting features and manifestations, such as constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders). Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to form the instant method of treating pain in a subject in need thereof comprising administering to the subject a therapeutically effective amount of anifrolumab, wherein the subject has SLE, and wherein the instant method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
Therefore, the claims of ‘671 render the instant claims obvious in view of Furie and Cojocaru. This is a provisional nonstatutory double patenting rejection.
Claims 11, 34-40, and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 10-24, and 27 of copending Application No. 19/485,479 (Tummala et al, Priority to 5/19/2023; hereinafter ‘479) and further in view of Furie et al (“Anifrolumab, an Anti-Interferon-α Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus”, Arthritis & Rheumatology, February 2017, 69(2):376-386), hereinafter Furie, and Cojocaru et al (“Manifestations of Systemic Lupus Erythematosus”, Maedica (Bucur), October 2011, 6(4):330-336), hereinafter Cojocaru. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 11, claims 1-3, 5, 10, and 27 of ‘479 recite a method of treating SLE in a subject in need thereof, comprising administering a therapeutically effective amount of anifrolumab to the subject, wherein the subject was diagnosed with SLE at an age of less than <30 years. Regarding instant claims 34-40 and 53, claims 11-24 of ‘479 recite the said method comprising administering anifrolumab to the subject intravenously at a dose of 300mg every four weeks or subcutaneously at a dose of 120mg every week.
However, 479 does not teach that the treatment method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
The deficiency is resolved by Furie and Cojocaru.
The teachings of Furie and Cojocaru are set forth above in the 103 rejection.
It would have been obvious for a person having ordinary skill in the art at the time of filing to modify the method of administering to a human subject with SLE a therapeutically effective amount of anifrolumab of ‘479 to include measuring FACIT-F and SF-36 in anifrolumab and placebo groups as taught by Furie since constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders) are common in SLE patients as taught by Cojocaru. This is obvious because, ‘479 teaches administering to a human subject with SLE a therapeutically effective amount of anifrolumab, Furie teaches subjects who received anifrolumab resulted in improvements from base line in the FACIT-F score, SF-36 MCS, and SF-36 PCS compared to subjects in the placebo group, and Cojocaru teaches that SLE is a chronic, multifaceted autoimmune inflammatory disease that can affect any part of the body with a variety of presenting features and manifestations, such as constitutional manifestations (e.g. fatigue), musculoskeletal manifestations (e.g. joint pains) and neurological manifestations (e.g. mood disorders). Therefore, it is obvious to a skilled artisan with reasonable expectation of success to have been motivated to form the instant method of treating pain in a subject in need thereof comprising administering to the subject a therapeutically effective amount of anifrolumab, wherein the subject has SLE, and wherein the instant method reduces fatigue in the subject, improves the subject’s mood, and improves the subject’s physical functioning.
Therefore, the claims of ‘479 render the instant claims obvious in view of Furie and Cojocaru. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jieun Ham whose telephone number is (571)272-7779. The examiner can normally be reached Monday - Friday 7-2.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.H./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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